The following data is part of a premarket notification filed by Biomet 3i Llc with the FDA for Bellatek Encode Emergence Healing Abutments.
| Device ID | K212730 |
| 510k Number | K212730 |
| Device Name: | BellaTek Encode Emergence Healing Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Biomet 3i LLC 4555 Riverside Drive 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
| Contact | Krupal Patel |
| Correspondent | Krupal Patel Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-30 |
| Decision Date | 2021-12-21 |