The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Dental Tapered Screw-vent X.
| Device ID | K113753 |
| 510k Number | K113753 |
| Device Name: | ZIMMER DENTAL TAPERED SCREW-VENT X |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Melissa Burbage |
| Correspondent | Melissa Burbage 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 | 2011-12-21 |
| Decision Date | 2012-08-30 |
| Summary: | summary |