The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Ti Prepable Abutment, Model 1618, 1619, 1620.
| Device ID | K092403 |
| 510k Number | K092403 |
| Device Name: | TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Larissa D Andrea Mcmullin |
| Correspondent | Larissa D Andrea Mcmullin 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 | 2009-08-06 |
| Decision Date | 2009-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024012134 | K092403 | 000 |
| 00889024012127 | K092403 | 000 |
| 00889024012110 | K092403 | 000 |