The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for 3.25 Spline Twist Implant, Ha Coated.
| Device ID | K093164 |
| 510k Number | K093164 |
| Device Name: | 3.25 SPLINE TWIST IMPLANT, HA COATED |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-06 |
| Decision Date | 2009-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024013315 | K093164 | 000 |
| 00889024013308 | K093164 | 000 |
| 00889024013292 | K093164 | 000 |
| 00889024013285 | K093164 | 000 |