The following data is part of a premarket notification filed by Biomet 3i with the FDA for Abutment For Competitive Implant Straumann Bone Level Connection.
| Device ID | K112730 |
| 510k Number | K112730 |
| Device Name: | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOMET 3I 4555 RIVERSIDE DRIVE Palm Beach Gardens, FL 33410 |
| Contact | Mayank Choudhary |
| Correspondent | Mayank Choudhary BIOMET 3I 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 | 2011-09-20 |
| Decision Date | 2012-01-13 |
| Summary: | summary |