The following data is part of a premarket notification filed by Biomet 3i with the FDA for Certain Bellatek Provisional Abutments.
| Device ID | K130310 |
| 510k Number | K130310 |
| Device Name: | CERTAIN BELLATEK PROVISIONAL ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOMET 3I 4555 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
| Contact | Jacquelyn A Hughes, Rac |
| Correspondent | Jacquelyn A Hughes, Rac BIOMET 3I 4555 RIVERSIDE DR. Palm Bch Gdns, 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 | 2013-02-07 |
| Decision Date | 2013-06-21 |
| Summary: | summary |