The following data is part of a premarket notification filed by Biomet 3i, Inc. with the FDA for Biomet 3i Patient Specific Dental Abutments-encode Abutments.
| Device ID | K101608 |
| 510k Number | K101608 |
| Device Name: | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Jose E Cabrera |
| Correspondent | Jose E Cabrera BIOMET 3I, INC. 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 | 2010-06-08 |
| Decision Date | 2011-03-11 |
| Summary: | summary |