The following data is part of a premarket notification filed by Intra-lock International with the FDA for Milo Dental Implant System.
| Device ID | K050970 |
| 510k Number | K050970 |
| Device Name: | MILO 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 | 2005-04-18 |
| Decision Date | 2005-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742MLW30170 | K050970 | 000 |
| D742MLHC0 | K050970 | 000 |
| D742MLAA150 | K050970 | 000 |
| 00847236017163 | K050970 | 000 |
| 00847236017156 | K050970 | 000 |
| 00847236017149 | K050970 | 000 |
| 00847236017132 | K050970 | 000 |
| 00847236017231 | K050970 | 000 |
| 00847236017217 | K050970 | 000 |
| 00847236017200 | K050970 | 000 |
| D742MLPA0 | K050970 | 000 |
| D742MLSA0 | K050970 | 000 |
| D742MLW30150 | K050970 | 000 |
| D742MLW30130 | K050970 | 000 |
| D742MLW30110 | K050970 | 000 |
| D742MLW30100 | K050970 | 000 |
| D742MLW37170 | K050970 | 000 |
| D742MLW37150 | K050970 | 000 |
| D742MLW37130 | K050970 | 000 |
| D742MLW37110 | K050970 | 000 |
| D742MLW37100 | K050970 | 000 |
| 00847236017248 | K050970 | 000 |