The following data is part of a premarket notification filed by Neoss, Ltd. with the FDA for Neoss Access Abutments.
| Device ID | K081851 |
| 510k Number | K081851 |
| Device Name: | NEOSS ACCESS ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NEOSS, LTD. WINDSOR HOUSE, CORNWALL RD. Harrogate, Yorkshire, GB Hg1 2pw |
| Contact | Fredrik Engman |
| Correspondent | Fredrik Engman NEOSS, LTD. WINDSOR HOUSE, CORNWALL RD. Harrogate, Yorkshire, GB Hg1 2pw |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2009-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060440333699 | K081851 | 000 |
| 05060440330605 | K081851 | 000 |
| 05060440330827 | K081851 | 000 |
| 05060440330902 | K081851 | 000 |
| 05060440331183 | K081851 | 000 |
| 05060440331190 | K081851 | 000 |
| 05060440331206 | K081851 | 000 |
| 05060440331213 | K081851 | 000 |
| 05060440331220 | K081851 | 000 |
| 05060440331237 | K081851 | 000 |
| 05060440331244 | K081851 | 000 |
| 05060440331473 | K081851 | 000 |
| 05060440333651 | K081851 | 000 |
| 05060440333668 | K081851 | 000 |
| 05060440333675 | K081851 | 000 |
| 05060440333736 | K081851 | 000 |