Implant Direct Sybron Manufacturing LLC
Thousand Oaks, CA, US
IMPLANT DIRECT SYBRON MANUFACTURING LLC appears in FDA device records in Thousand Oaks, CA. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Implant Direct Sybron Manufacturing LLC between 2013 and 2023. The busiest year on record is 2020, with 4. The most recent is 2023, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 2 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 2 |
| 2023 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231087 | Guided Surgery Kit | DZI | Substantially Equivalent | |
| K223535 | SMARTbase Abutment System | NHA | Substantially Equivalent | |
| K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | DZE | Substantially Equivalent | |
| K202524 | Standard Sterilizable Tray | KCT | Substantially Equivalent | |
| K201553 | Simply Iconic Implants | DZE | Substantially Equivalent | |
| K200858 | Mini Sterilizable Tray | KCT | Substantially Equivalent | |
| K200265 | Surgical Drills | DZI | Substantially Equivalent | |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | DZE | Substantially Equivalent | |
| K192218 | Custom Legacy and Custom InterActive Titanium Abutments | NHA | Substantially Equivalent | |
| K191458 | Legacy SMARTBase Abutments | NHA | Substantially Equivalent | |
| K181359 | InterActive SMARTBase Abutments | NHA | Substantially Equivalent | |
| K162633 | Custom Bars | NHA | Substantially Equivalent | |
| K153509 | GPS Angled Abutment | NHA | Substantially Equivalent | |
| K143011 | 2014 InterActive/SwishActive System | DZE | Substantially Equivalent | |
| K142519 | InterActive Complete Surgical Tray | KCT | Substantially Equivalent | |
| K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K131097 | LEGACY3 6MM LENGTH IMPLANTS | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001617766 | 3001617766 | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 3050 East Hillcrest Drive, Thousand Oaks, CA 91362 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
- EGGAttachment, Precision, All
- EJLBur, Dental
- PNPDental Abutment Design Software For Dental Laboratory
- DZIDrill, Bone, Powered
- DZEImplant, Endosseous, Root-Form
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2172-2025 | The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short 6-13mm depth, and Long 6-16mm depth), and in several diameters for different diameter drills. | The Drill stop kit contains incorrect components. | Class II | Open, Classified | |
| Z-2037-2023 | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE; | Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established. | Class II | Open, Classified | |
| Z-0198-2022 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Open, Classified | |
| Z-0197-2022 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Open, Classified | |
| Z-1157-2020 | Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R, | Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery. | Class II | Terminated | |
| Z-1041-2020 | Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 | Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. | Class II | Terminated | |
| Z-0364-2020 | Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. | Class II | Terminated | |
| Z-1126-2020 | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia. | Class II | Terminated | |
| Z-0791-2020 | ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. | The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion. | Class II | Completed | |
| Z-0790-2020 | ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. | The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion. | Class II | Completed | |
| Z-0363-2020 | Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant | packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit. | Class II | Terminated | |
| Z-0261-2020 | Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958 | The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient. | Class II | Terminated | |
| Z-0018-2020 | ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. | Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. | Class II | Terminated | |
| Z-0010-2020 | ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. | The incorrect device was packaged in the vial. | Class II | Terminated | |
| Z-0089-2019 | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure. | Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label. | Class II | Terminated | |
| Z-2376-2018 | REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 | Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant | Class II | Terminated | |
| Z-1917-2018 | ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. | The cap on the vial might be labeled with the incorrect part number but the main vial label is correct. | Class II | Terminated | |
| Z-0539-2018 | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized. | Class II | Terminated | |
| Z-1168-2018 | SwishPlus Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer). | Class II | Terminated | |
| Z-1167-2018 | SwishTapered Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer). | Class II | Terminated | |
| Z-0283-2018 | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide. | The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large. | Class II | Terminated | |
| Z-0185-2018 | ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. | One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised. | Class II | Terminated | |
| Z-0007-2018 | Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component. | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. | Class II | Terminated | |
| Z-3115-2017 | Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide. | The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require. | Class II | Terminated | |
| Z-2125-2017 | Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain