The following data is part of a premarket notification filed by Simpact Llc with the FDA for Simpact Implant System.
| Device ID | K081226 |
| 510k Number | K081226 |
| Device Name: | SIMPACT IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SIMPACT LLC 300 INTERPACE PARKWAY BUILDING C 3RD FLOOR Parsippany, NJ 07054 |
| Contact | Alan Lombardo |
| Correspondent | Alan Lombardo SIMPACT LLC 300 INTERPACE PARKWAY BUILDING C 3RD FLOOR Parsippany, NJ 07054 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-30 |
| Decision Date | 2008-09-12 |
| Summary: | summary |