The following data is part of a premarket notification filed by Simpact Llc with the FDA for Simpact Endosseous Dental Implant System.
| Device ID | K083141 |
| 510k Number | K083141 |
| Device Name: | SIMPACT ENDOSSEOUS DENTAL IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | SIMPACT LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Contact | Mark Schenk |
| Correspondent | Mark Schenk SIMPACT LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany, NJ 07054 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-23 |
| Decision Date | 2008-11-07 |
| Summary: | summary |