Keystone Dental Inc.
Irvine, CA, US
Keystone Dental Inc. appears in FDA device records in Irvine, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 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 8 510(k) clearances for Keystone Dental Inc. between 2007 and 2024. The busiest year on record is 2007, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240966 | Prima Plus Conical Implant System | DZE | Substantially Equivalent | |
| K223814 | Genesis ACTIVE Implant System | DZE | Substantially Equivalent | |
| K221381 | KDG Abutments | NHA | Substantially Equivalent | |
| K201334 | Keystone Dental XL Dental Implant System | DZE | Substantially Equivalent | |
| K101545 | GENESIS IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K090397 | XPI ANGLED ABUTMENTS | NHA | Substantially Equivalent | |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K071599 | EASYGUIDE | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011936113 | 3011936113 | Keystone Dental Inc. | 13645 Alton Pkwy Ste A, Irvine, CA 92618 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- NUNBone Grafting Material, Human Source
- LYCBone Grafting Material, Synthetic
- EJLBur, Dental
- OFYDental Implant Surgical Tray
- DZADrill, Dental, Intraoral
- EILGauge, Depth, Instrument, Dental
- EJBHandle, Instrument, Dental
- DZEImplant, Endosseous, Root-Form
- DZNInstruments, Dental Hand
- LLZSystem, Image Processing, Radiological
- ELLTeeth, Porcelain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1064-2019 | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | Class II | Terminated | |
| Z-1063-2019 | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | Class II | Terminated | |
| Z-1062-2019 | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | Class II | Terminated | |
| Z-1061-2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature | Class II | Terminated | |
| Z-2162-2018 | Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. | The implants are mislabeled. | Class II | Terminated | |
| Z-1485-2018 | Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket | The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette. | Class II | Terminated | |
| Z-1443-2018 | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. | The cutting edge of tissue punches may be potentially damaged with small dents and nicks. | Class II | Terminated | |
| Z-1179-2018 | STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K | A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve. | Class III | Terminated | |
| Z-0727-2018 | Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework. | The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06. | Class II | Terminated | |
| Z-0608-2018 | Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework. | Abutments are unable to accept the final abutment screw | Class II | Terminated | |
| Z-0718-2018 | Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw. | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. | Class II | Terminated | |
| Z-1818-2017 | Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants | Class II | Terminated | |
| Z-0299-2017 | Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) | Class II | Terminated | |
| Z-0973-2013 | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework. | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled | Class II | Terminated | |
| Z-0924-2013 | Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment | Class II | Terminated | |
| Z-0923-2013 | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment, | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain