The following data is part of a premarket notification filed by Biomet 3i with the FDA for Tsv Bellatek Encode Healing Abutments.
| Device ID | K173374 |
| 510k Number | K173374 |
| Device Name: | TSV BellaTek Encode Healing Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
| Contact | Nichole O’neil |
| Correspondent | Linda K. Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-27 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868041023 | K173374 | 000 |
| 00844868040903 | K173374 | 000 |
| 00844868040910 | K173374 | 000 |
| 00844868040927 | K173374 | 000 |
| 00844868040934 | K173374 | 000 |
| 00844868040941 | K173374 | 000 |
| 00844868040958 | K173374 | 000 |
| 00844868040965 | K173374 | 000 |
| 00844868040972 | K173374 | 000 |
| 00844868040989 | K173374 | 000 |
| 00844868040996 | K173374 | 000 |
| 00844868041009 | K173374 | 000 |
| 00844868041016 | K173374 | 000 |
| 00844868040897 | K173374 | 000 |