The following data is part of a premarket notification filed by Intra-lock International with the FDA for Mini Drive-lock Dental Implant System.
| Device ID | K070601 |
| 510k Number | K070601 |
| Device Name: | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTRA-LOCK INTERNATIONAL 1200 NORTH FEDERAL HWY. SUITE 209 Boca Raton, FL 33432 |
| Contact | Jeffrey Sakoff |
| Correspondent | Jeffrey Sakoff INTRA-LOCK INTERNATIONAL 1200 NORTH FEDERAL HWY. SUITE 209 Boca Raton, FL 33432 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-02 |
| Decision Date | 2007-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236013844 | K070601 | 000 |
| 00847236013981 | K070601 | 000 |
| 00847236013998 | K070601 | 000 |
| 00847236014025 | K070601 | 000 |
| 00847236014032 | K070601 | 000 |
| 00847236014063 | K070601 | 000 |
| 00847236014070 | K070601 | 000 |
| 00847236014100 | K070601 | 000 |
| 00847236014117 | K070601 | 000 |
| D742MDL2011S0 | K070601 | 000 |
| 00847236013967 | K070601 | 000 |
| 00847236013950 | K070601 | 000 |
| 00847236013851 | K070601 | 000 |
| 00847236013868 | K070601 | 000 |
| 00847236013875 | K070601 | 000 |
| 00847236013882 | K070601 | 000 |
| 00847236013899 | K070601 | 000 |
| 00847236013905 | K070601 | 000 |
| 00847236013912 | K070601 | 000 |
| 00847236013929 | K070601 | 000 |
| 00847236013936 | K070601 | 000 |
| D742MDL2518S0 | K070601 | 000 |
| D742MDLOP25180 | K070601 | 000 |
| D742MDL2511S0 | K070601 | 000 |
| D742MDL25130 | K070601 | 000 |
| D742MDL2513S0 | K070601 | 000 |
| D742MDL25150 | K070601 | 000 |
| D742MDL2515S0 | K070601 | 000 |
| D742MDL25180 | K070601 | 000 |
| D742MDL2513A0 | K070601 | 000 |
| D742MDL2515A0 | K070601 | 000 |
| D742MDL2518A0 | K070601 | 000 |
| D742MDL25110 | K070601 | 000 |
| D742MDL2510S0 | K070601 | 000 |
| D742MDL20100 | K070601 | 000 |
| D742MDL2010S0 | K070601 | 000 |
| D742MDL20130 | K070601 | 000 |
| D742MDL2013S0 | K070601 | 000 |
| D742MDL20150 | K070601 | 000 |
| D742MDL2015S0 | K070601 | 000 |
| D742MDL2018 | K070601 | 000 |
| D742MDL2018S0 | K070601 | 000 |
| D742MDL25100 | K070601 | 000 |
| D742MDL20110 | K070601 | 000 |