Straumann USA, LLC
Andover, MA, US
Straumann USA, LLC appears in FDA device records in Andover, MA. FDA records list 176 510(k) clearances between and , 35 PMA records and 4 registered establishments. As of , FDA records show 49 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Straumann USA, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Institut Straumann SAregistration, 510(k)
- Instradent USA, Inc.enforcement report, recall
- Straumann Manufacturing, Inc.registration, 510(k), enforcement report, recall
- The Straumann Co.510(k), PMA, recall
510(k) clearance history
Showing 50 of 176FDA records hold 176 510(k) clearances for Straumann USA, LLC between 1990 and 2026. The busiest year on record is 2007, with 13. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 3 |
| 1992 | 3 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 5 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 5 |
| 2000 | 2 |
| 2001 | 6 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 7 |
| 2005 | 2 |
| 2006 | 6 |
| 2007 | 13 |
| 2008 | 8 |
| 2009 | 7 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 6 |
| 2013 | 4 |
| 2014 | 6 |
| 2015 | 7 |
| 2016 | 5 |
| 2017 | 8 |
| 2018 | 11 |
| 2019 | 10 |
| 2020 | 5 |
| 2021 | 9 |
| 2022 | 4 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | KCT | Substantially Equivalent | |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | NHA | Substantially Equivalent | |
| K252168 | Straumann® BLC Implants - Indication Widening | DZE | Substantially Equivalent | |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | NHA | Substantially Equivalent | |
| K250294 | Straumann® RidgeFit Implants | DZE | Substantially Equivalent | |
| K243278 | Custom Abutments | NHA | Substantially Equivalent | |
| K243478 | Straumann InLab Validated Workflow | NHA | Substantially Equivalent | |
| K233252 | Straumann CARES Visual and Nova Dental CAD | PNP | Substantially Equivalent | |
| K241391 | Straumann® PURE Ceramic Implants | DZE | Substantially Equivalent | |
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | NHA | Substantially Equivalent | |
| K234049 | Straumann® BLC and TLC Implants - Line extension | DZE | Substantially Equivalent | |
| K230108 | Straumann® BLC and TLC Implants | DZE | Substantially Equivalent | |
| K223083 | Straumann SLActive labeling changes | DZE | Substantially Equivalent | |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | NHA | Substantially Equivalent | |
| K220878 | Straumann TLX Variobase C | NHA | Substantially Equivalent | |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | NHA | Substantially Equivalent | |
| K213063 | TLX SRAs and TLX Gold Abutments | NHA | Substantially Equivalent | |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | DZE | Substantially Equivalent | |
| K203750 | Straumann CARES P-Series CAD/CAM System | NHA | Substantially Equivalent | |
| K203753 | Straumann Surgical Cassettes | KCT | Substantially Equivalent | |
| K211052 | Straumann RidgeFit Implants | DZE | Substantially Equivalent | |
| K203456 | Straumann CARES M-Series CAD/CAM System | NHA | Substantially Equivalent | |
| K210855 | Straumann BLX Implant System | DZE | Substantially Equivalent | |
| K201681 | Straumann Immediate Temporary Abutments | NHA | Substantially Equivalent | |
| K203355 | Straumann TLX Novaloc and Cementable Abutments | NHA | Substantially Equivalent | |
| K192742 | Straumann Variobase C | NHA | Substantially Equivalent | |
| K202942 | Straumann 4 mm Short Implants | DZE | Substantially Equivalent | |
| K201051 | Straumann BoneCeramic | LYC | Substantially Equivalent | |
| K200586 | Straumann TLX Implant System | DZE | Substantially Equivalent | |
| K193046 | Straumann® Retentive System – Novaloc TiN Abutments | NHA | Substantially Equivalent | |
| K192401 | Straumann Screw-Retained Abutments | NHA | Substantially Equivalent | |
| K192893 | Straumann Ceramic Healing Abutments | NHA | Substantially Equivalent | |
| K191256 | Straumann BLX Ø3.5 mm Implants | DZE | Substantially Equivalent | |
| K191895 | Straumann Mini Implants | DZE | Substantially Equivalent | |
| K191522 | Straumann Modular Cassette | KCT | Substantially Equivalent | |
| K192029 | Straumann PUREloc abutments | NHA | Substantially Equivalent | |
| K190654 | Straumann CI RD Ceramic Healing Caps | NHA | Substantially Equivalent | |
| K190097 | Straumann CARES Screw-Retained Bridges and Bars | NHA | Substantially Equivalent | |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | DZE | Substantially Equivalent | |
| K190082 | Straumann BLX Variobase Abutment | NHA | Substantially Equivalent | |
| K190040 | Straumann BLX Line Extension - New Abutments | NHA | Substantially Equivalent | |
| K180477 | Straumann PURE Ceramic Implant System | DZE | Substantially Equivalent | |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | DZE | Substantially Equivalent | |
| K173594 | Straumann cerabone | NPM | Substantially Equivalent | |
| K173945 | Straumann SC Variobase Abutments | NHA | Substantially Equivalent | |
| K173968 | Straumann Variobase for Bridge/Bar Cylindrical | NHA | Substantially Equivalent | |
| K173562 | Straumann Jason Membrane | NPL | Substantially Equivalent | |
| K180791 | Straumann BLX Surgical Cassette | KCT | Substantially Equivalent | |
| K173961 | Straumann BLX Implant System | DZE | Substantially Equivalent | |
| K173379 | Straumann Variobase for Crown AS | NHA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613348 | 3004975279 | INSTITUT STRAUMANN AG | PETER MERIAN-WEG 12, BASEL Basel-Stadt CH-4002 CH | 2026 | and 17 more, listed in full below |
| 3024185724 | 3024185724 | Straumann Manufacturing, Inc. | 1961 Heritage Parkway, Mansfield, TX 76063 US | 2026 | and 1 more, listed in full below |
| 3033781108 | 3033781108 | Straumann Manufacturing, Inc. | 60 Minuteman Road, Andover, MA 01810 US | 2026 | |
| 1222315 | 1000121052 | Straumann USA, LLC | 60 MINUTEMAN RD., ANDOVER, MA 01810 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EJHAlloy, Metal, Base
- EJXAnchor, Preformed
- EGGAttachment, Precision, All
- EHOBar, Preformed
- NPLBarrier, Animal Source, Intraoral
- NPKBarrier, Synthetic, Intraoral
- NQABiologic Material, Dental
- NPMBone Grafting Material, Animal Source
- LYCBone Grafting Material, Synthetic
- EJLBur, Dental
- EMMChisel, Osteotome, Surgical
- KJJCleanser, Root Canal
- EBGCrown And Bridge, Temporary, Resin
- PNPDental Abutment Design Software For Dental Laboratory
- DZIDrill, Bone, Powered
- DZJDriver, Wire, And Bone Drill, Manual
- EMHForceps, Rongeur, Surgical
- OATImplant, Endosseous, Orthodontic
- DZEImplant, Endosseous, Root-Form
- EBFMaterial, Tooth Shade, Resin
- GDMNeedle, Aspiration And Injection, Reusable
- JEYPlate, Bone
- EIHPowder, Porcelain
- KCZProsthesis, Breast, External, Used With Adhesive
- EMEPunch, Biopsy, Surgical
- ELBScaler, Rotary
- DZLScrew, Fixation, Intraosseous
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- LLZSystem, Image Processing, Radiological
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Recall records
Showing 25 of 49| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2935-2026 | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest. | Class II | Open, Classified | |
| Z-2929-2026 | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 | There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume | Class II | Open, Classified | |
| Z-1995-2026 | Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments | Includes an incorrect screw seat interface. | Class II | Open, Classified | |
| Z-1994-2026 | Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments | Includes an incorrect screw seat interface. | Class II | Open, Classified | |
| Z-1633-2026 | Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06. | Class II | Open, Classified | |
| Z-1632-2026 | Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; | A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06. | Class II | Open, Classified | |
| Z-1337-2026 | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. | Class III | Open, Classified | |
| Z-0582-2026 | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; | The possibility for this product that is intended for demonstration purposes only to be placed in patients. | Class II | Open, Classified | |
| Z-1863-2025 | GM Helix Acqua Implant, Article Number: 140.985 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Open, Classified | |
| Z-1862-2025 | GM Helix Acqua Implant, Article Number: 140.984 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Open, Classified | |
| Z-1671-2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Incorrect blister labelling. | Class II | Open, Classified | |
| Z-1861-2025 | Plus Initial Drill, Article Number: 103.170; | The referred batch was produced without the laser engraving of 7 mm. | Class II | Open, Classified | |
| Z-1561-2025 | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | The devices are missing the laser marked depth markings. | Class II | Open, Classified | |
| Z-0513-2022 | Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant | Class II | Terminated | |
| Z-0512-2022 | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant | Class II | Terminated | |
| Z-2336-2021 | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005 | Product label intended for the European community was distributed to the USA market via their US distribution organization | Class II | Open, Classified | |
| Z-2198-2021 | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument. | Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury | Class II | Terminated | |
| Z-0455-2019 | Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244 | Laser engraved label does not match with the item in the package | Class II | Terminated | |
| Z-1698-2018 | Straumann Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | Class II | Terminated | |
| Z-1697-2018 | Straumann Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115 | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | Class II | Terminated | |
| Z-1696-2018 | Straumann Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | Class II | Terminated | |
| Z-1695-2018 | Straumann Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113 | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | Class II | Terminated | |
| Z-1694-2018 | Straumann Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | Class II | Terminated | |
| Z-1693-2018 | Straumann Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | Class II | Terminated | |
| Z-1831-2017 | NEODENT CM Intraoral Scanbody, Article Number: 108.139 | During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain