The following data is part of a premarket notification filed by Northern Implants, Llc with the FDA for Nsi Hexed And Non-hexed Implant System And Immediate Loading.
| Device ID | K033171 |
| 510k Number | K033171 |
| Device Name: | NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NORTHERN IMPLANTS, LLC 10565 LEE HIGHWAY SUITE 100 Fairfax, VA 22030 |
| Contact | Greta Hols |
| Correspondent | Greta Hols NORTHERN IMPLANTS, LLC 10565 LEE HIGHWAY SUITE 100 Fairfax, VA 22030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D768DBS240 | K033171 | 000 |
| D768DBS120 | K033171 | 000 |