The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing , Llc with the FDA for Custom Legacy And Custom Interactive Titanium Abutments.
| Device ID | K192218 |
| 510k Number | K192218 |
| Device Name: | Custom Legacy And Custom InterActive Titanium Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Implant Direct Sybron Manufacturing , LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Contact | Reina Choi |
| Correspondent | Kelliann Payne Hogan Lovells LLP 1735 Market Street 23rd Floor Philadelphia, PA 19103 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-15 |
| Decision Date | 2020-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307116875 | K192218 | 000 |
| 10841307116868 | K192218 | 000 |
| 10841307116851 | K192218 | 000 |
| 10841307116844 | K192218 | 000 |
| 10841307116837 | K192218 | 000 |
| 10841307116820 | K192218 | 000 |