The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing Llc with the FDA for Legacy Smartbase Abutments.
| Device ID | K191458 |
| 510k Number | K191458 |
| Device Name: | Legacy SMARTBase Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Contact | Reina Choi |
| Correspondent | Yarmela Pavlovic Hogan Lovells U.S. LLP 3 Embarcadero Center #1500 San Francisco, CA 94111 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-31 |
| Decision Date | 2019-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307122807 | K191458 | 000 |
| 10841307129967 | K191458 | 000 |
| 10841307129974 | K191458 | 000 |
| 10841307127383 | K191458 | 000 |
| 10841307127390 | K191458 | 000 |
| 10841307127406 | K191458 | 000 |
| 10841307122975 | K191458 | 000 |
| 10841307122982 | K191458 | 000 |
| 10841307122999 | K191458 | 000 |
| 10841307122715 | K191458 | 000 |
| 10841307122722 | K191458 | 000 |
| 10841307122739 | K191458 | 000 |
| 10841307122746 | K191458 | 000 |
| 10841307122753 | K191458 | 000 |
| 10841307122760 | K191458 | 000 |
| 10841307122777 | K191458 | 000 |
| 10841307122784 | K191458 | 000 |
| 10841307122791 | K191458 | 000 |
| 10841307129950 | K191458 | 000 |