The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Plastic Temporary Abutments, Models: Pt341s, Pt344s, Pt341a, Pt344a, Pt451s, Pt454s, Pt451a, Pt454a, Pt561s, Pt564s.
| Device ID | K092377 |
| 510k Number | K092377 |
| Device Name: | PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | William Fisher |
| Correspondent | William Fisher ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024014640 | K092377 | 000 |
| 00889024016606 | K092377 | 000 |
| 00889024016613 | K092377 | 000 |
| 00889024016620 | K092377 | 000 |
| 00889024016637 | K092377 | 000 |
| 00889024016644 | K092377 | 000 |
| 00889024016651 | K092377 | 000 |
| 00889024016668 | K092377 | 000 |
| 00889024016675 | K092377 | 000 |
| 00889024016682 | K092377 | 000 |
| 00889024016590 | K092377 | 000 |