The following data is part of a premarket notification filed by Biomet 3i with the FDA for Eztetic Bellatek Encode Healing Abutments.
| Device ID | K170013 |
| 510k Number | K170013 |
| Device Name: | Eztetic BellaTek Encode Healing Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOMET 3I 4555 RIVERSIDE DR Palm Beach Gardens, FL 33410 |
| Contact | Krupal Patel |
| Correspondent | Krupal Patel BIOMET 3I 4555 RIVERSIDE DR Palm Beach Gardens, FL 33410 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-09-21 |
| Summary: | summary |