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Sign in to claim this brandKeystone Dental Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 13645 Alton Pkwy Ste A, Irvine, CA, 92618
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011936113
- DUNS Number
- —
Catalogue (2088)
Page 42 of 42| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Stage-1 | S1100-28-10K | FDA UDI | Class I | Active |
| Renova Implant System | 13008K | FDA UDI | Class II | Unknown |
| Restore | L1502-50-13K | FDA UDI | Class I | Active |
| Restore | L2405-50-01K | FDA UDI | Class II | Active |
| Oct Implant System | ITST12D-512 | FDA UDI | Class II | Unknown |
| ExHex | TB2 | FDA UDI | Class II | Unknown |
| ExHex | TSH2 | FDA UDI | Class II | Unknown |
| ExHex | ABAMCZ3 | FDA UDI | Class II | Unknown |
| ExHex | DBA3.5 | FDA UDI | Class II | Unknown |
| ExHex | GMCW1 | FDA UDI | Class II | Unknown |
| Restore | L2400-50-01K | FDA UDI | Class II | Active |
| Ex Hex Implant System | BBBT 24D-13 | FDA UDI | Class II | Unknown |
| Restore | R9655-34-02K | FDA UDI | Class II | Active |
| Renova | 43109K | FDA UDI | Class II | Unknown |
| Restore | L2505-60-02K | FDA UDI | Class II | Active |
| Stage 1 | 42001K | FDA UDI | Class II | Active |
| Restore | L1100-42-10K | FDA UDI | Class I | Active |
| ExHex | WBBB4 | FDA UDI | Class II | Unknown |
| Oct Implant System | ITT410 | FDA UDI | Class II | Unknown |
| Tri-Nex Implant System | IA-LH-43-16 | FDA UDI | Class II | Unknown |
| ExHex | WBA4 | FDA UDI | Class II | Unknown |
| Restore | L2100-85-24K | FDA UDI | Class I | Active |
| ExHex | P-CAP-55 | FDA UDI | Class II | Unknown |
| Renova | 43106K | FDA UDI | Class II | Unknown |
| ExHex | HMCTW9-4 | FDA UDI | Class II | Unknown |
| Stage 1 | 42007K | FDA UDI | Class II | Active |
| Stage-1 | S1803-42K | FDA UDI | Class I | Active |
| Restore | L1104-20-15K | FDA UDI | Class I | Active |
| Restore | L1504-38-13K | FDA UDI | Class I | Active |
| Tri-Nex Implant System | IA-LH-35-13 | FDA UDI | Class II | Unknown |
| Genesis Implant System | K101545 | FDA 510(k) | Class II | Active |
| Easyguide | K071599 | FDA 510(k) | Class II | Active |
| Keystone Dental XL Dental Implant System | K201334 | FDA 510(k) | Class II | Active |
| Xpi Angled Abutments | K090397 | FDA 510(k) | Class II | Active |
| KDG Abutments | K221381 | FDA 510(k) | Class II | Active |
| Genesis ACTIVE Implant System | K223814 | FDA 510(k) | Class II | Active |
| Prima Plus Conical Implant System | K240966 | FDA 510(k) | Class II | Active |
| Olympus Dental Implant System | K071070 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (16)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 22, 2019 | Z-1061-2019 | — | terminated | 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 |
| Feb 22, 2019 | Z-1062-2019 | — | terminated | 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 |
| Feb 22, 2019 | Z-1063-2019 | — | terminated | 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 |
| Feb 22, 2019 | Z-1064-2019 | — | terminated | 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 |
| May 1, 2018 | Z-2162-2018 | — | terminated | The implants are mislabeled. |
| Mar 13, 2018 | Z-1485-2018 | — | terminated | 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. |
| Jan 24, 2018 | Z-1443-2018 | — | terminated | The cutting edge of tissue punches may be potentially damaged with small dents and nicks. |
| Oct 16, 2017 | Z-1179-2018 | — | terminated | 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. |
| Aug 25, 2017 | Z-0727-2018 | — | terminated | 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. |
| Jun 20, 2017 | Z-0608-2018 | — | terminated | Abutments are unable to accept the final abutment screw |
| Jun 16, 2017 | Z-0718-2018 | — | terminated | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label. |
| Mar 9, 2017 | Z-1818-2017 | — | terminated | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants |
| Sep 15, 2016 | Z-0299-2017 | — | terminated | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) |
| Mar 11, 2013 | Z-0973-2013 | — | terminated | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled |
| Jul 5, 2011 | Z-0923-2013 | — | terminated | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment, |
| Jul 5, 2011 | Z-0924-2013 | — | terminated | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment |