The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Dental Trabecular Metal Implant System.
| Device ID | K132258 |
| 510k Number | K132258 |
| Device Name: | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Julie L Corman |
| Correspondent | Julie L Corman 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 | 2013-07-19 |
| Decision Date | 2013-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024019027 | K132258 | 000 |
| 00889024019010 | K132258 | 000 |
| 00889024019003 | K132258 | 000 |
| 00889024018990 | K132258 | 000 |
| 00889024018891 | K132258 | 000 |
| 00889024018884 | K132258 | 000 |
| 00889024018877 | K132258 | 000 |
| 00889024018860 | K132258 | 000 |