The following data is part of a premarket notification filed by Intra-lock International with the FDA for Intra-lock Op Dental Implant.
| Device ID | K130140 |
| 510k Number | K130140 |
| Device Name: | INTRA-LOCK OP DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTRA-LOCK INTERNATIONAL 6560 WEST ROGERS CIRCLE SUITE 24 Boca Raton, FL 33487 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor INTRA-LOCK INTERNATIONAL 6560 WEST 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 | 2013-01-22 |
| Decision Date | 2013-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742OPHC20 | K130140 | 000 |
| D742OPS30150 | K130140 | 000 |
| D742OPS30130 | K130140 | 000 |
| D742OPS30110 | K130140 | 000 |
| D742OPS30100 | K130140 | 000 |
| D742FTRS0 | K130140 | 000 |
| D742FTCRS0 | K130140 | 000 |
| D742FTARS0 | K130140 | 000 |