The following data is part of a premarket notification filed by Intra-lock International with the FDA for Intra-lock International Angled Prosthetic Abutments.
| Device ID | K040205 |
| 510k Number | K040205 |
| Device Name: | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INTRA-LOCK INTERNATIONAL 1200 NORTH FEDERAL HWY SUITE 200 Boca Raton, FL 33432 |
| Contact | Jeffery Sakoff |
| Correspondent | Jeffery Sakoff INTRA-LOCK INTERNATIONAL 1200 NORTH FEDERAL HWY SUITE 200 Boca Raton, FL 33432 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-30 |
| Decision Date | 2004-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742SCS170 | K040205 | 000 |