The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Dental Tapered Screw Vent T Implant, Ha Coated;zimmer Dental Tapered Screw-vent M Implant, Ha Coated.
| Device ID | K133339 |
| 510k Number | K133339 |
| Device Name: | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED |
| 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 | 2013-10-30 |
| Decision Date | 2014-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024344389 | K133339 | 000 |
| 00889024344105 | K133339 | 000 |
| 00889024344112 | K133339 | 000 |
| 00889024344129 | K133339 | 000 |
| 00889024344136 | K133339 | 000 |
| 00889024344143 | K133339 | 000 |
| 00889024344150 | K133339 | 000 |
| 00889024344167 | K133339 | 000 |
| 00889024344174 | K133339 | 000 |
| 00889024344099 | K133339 | 000 |
| 00889024344082 | K133339 | 000 |
| 00889024344006 | K133339 | 000 |
| 00889024344013 | K133339 | 000 |
| 00889024344020 | K133339 | 000 |
| 00889024344037 | K133339 | 000 |
| 00889024344044 | K133339 | 000 |
| 00889024344051 | K133339 | 000 |
| 00889024344068 | K133339 | 000 |
| 00889024344075 | K133339 | 000 |
| 00889024344181 | K133339 | 000 |
| 00889024344198 | K133339 | 000 |
| 00889024344303 | K133339 | 000 |
| 00889024344310 | K133339 | 000 |
| 00889024344327 | K133339 | 000 |
| 00889024344334 | K133339 | 000 |
| 00889024344341 | K133339 | 000 |
| 00889024344358 | K133339 | 000 |
| 00889024344365 | K133339 | 000 |
| 00889024344372 | K133339 | 000 |
| 00889024344297 | K133339 | 000 |
| 00889024344280 | K133339 | 000 |
| 00889024344204 | K133339 | 000 |
| 00889024344211 | K133339 | 000 |
| 00889024344228 | K133339 | 000 |
| 00889024344235 | K133339 | 000 |
| 00889024344242 | K133339 | 000 |
| 00889024344259 | K133339 | 000 |
| 00889024344266 | K133339 | 000 |
| 00889024344273 | K133339 | 000 |
| 00889024343993 | K133339 | 000 |