The following data is part of a premarket notification filed by Intra-lock International, Inc. with the FDA for Intra-lock Dental Implants With Blossom 3.4mm Implant Angled Abutments.
| Device ID | K111199 |
| 510k Number | K111199 |
| Device Name: | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INTRA-LOCK INTERNATIONAL, INC. 6560 WEST ROGERS CIRCLE Boca Raton, FL 33487 |
| Contact | Angela Blackwell |
| Correspondent | Angela Blackwell INTRA-LOCK INTERNATIONAL, INC. 6560 WEST ROGERS CIRCLE Boca Raton, FL 33487 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-28 |
| Decision Date | 2011-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742IAA150 | K111199 | 000 |