The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Tapered Screw-vent X Implant.
| Device ID | K112160 |
| 510k Number | K112160 |
| Device Name: | TAPERED SCREW-VENT X IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich 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 | 2011-07-27 |
| Decision Date | 2011-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024019058 | K112160 | 000 |
| 00889024018815 | K112160 | 000 |
| 00889024018822 | K112160 | 000 |
| 00889024018839 | K112160 | 000 |
| 00889024018846 | K112160 | 000 |
| 00889024018853 | K112160 | 000 |
| 00889024018907 | K112160 | 000 |
| 00889024018914 | K112160 | 000 |
| 00889024018921 | K112160 | 000 |
| 00889024018938 | K112160 | 000 |
| 00889024018945 | K112160 | 000 |
| 00889024018952 | K112160 | 000 |
| 00889024018969 | K112160 | 000 |
| 00889024018976 | K112160 | 000 |
| 00889024018983 | K112160 | 000 |
| 00889024019034 | K112160 | 000 |
| 00889024019041 | K112160 | 000 |
| 00889024018808 | K112160 | 000 |