The following data is part of a premarket notification filed by Intra-lock International, Inc. with the FDA for Intra-lock Dental Implants.
| Device ID | K133613 |
| 510k Number | K133613 |
| Device Name: | INTRA-LOCK DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTRA-LOCK INTERNATIONAL, INC. 6560 W. ROGERS CIRCLE SUITE 24 Boca Raton, FL 33487 |
| Contact | Mary L Jean |
| Correspondent | Mary L Jean INTRA-LOCK INTERNATIONAL, INC. 6560 W. ROGERS CIRCLE SUITE 24 Boca Raton, FL 33487 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-25 |
| Decision Date | 2014-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742IC5011TI0 | K133613 | 000 |
| D742IC4310STI0 | K133613 | 000 |
| D742IC4311STI0 | K133613 | 000 |
| D742IC4315STI0 | K133613 | 000 |
| D742IC5010STI0 | K133613 | 000 |
| D742IC5011STI0 | K133613 | 000 |
| D742IC5013STI0 | K133613 | 000 |
| D742IC5015STI0 | K133613 | 000 |
| D742IS3711TI0 | K133613 | 000 |
| D742IS3713TI0 | K133613 | 000 |
| D742IS3715TI0 | K133613 | 000 |
| D742I4011STI0 | K133613 | 000 |
| D742IC4313STI0 | K133613 | 000 |