The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Screw-vent Implant System, Sv;tapered Screw -vent Implant System, Tsv;advent Implant System,av;zimmer One-piece Implant.
| Device ID | K061410 |
| 510k Number | K061410 |
| Device Name: | SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Floyd Larson |
| Correspondent | Floyd Larson ZIMMER DENTAL INC. 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-22 |
| Decision Date | 2006-09-08 |
| Summary: | summary |