The following data is part of a premarket notification filed by Neoss Ltd with the FDA for Neoss Tibase, Neoss Cocr Abutments (mono And Multi).
| Device ID | K150669 |
| 510k Number | K150669 |
| Device Name: | Neoss TiBase, Neoss CoCr Abutments (Mono And Multi) |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Neoss Ltd Windsor House Cornwall Road Harrogate, GB Hg1 2pw |
| Contact | Karin Darle Olsson |
| Correspondent | Cherita James M SQUARED ASSOCIATES, INC. 575 8TH AVENUE, SUITE1212 New York, NY 10018 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060440333712 | K150669 | 000 |
| 05060440333552 | K150669 | 000 |
| 05060440331503 | K150669 | 000 |
| 05060440331497 | K150669 | 000 |
| 05060440331329 | K150669 | 000 |
| 05060440331312 | K150669 | 000 |
| 05060440331305 | K150669 | 000 |
| 05060440330636 | K150669 | 000 |