The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Tapered Screw-vent Implant, 4.1mm, Models: Tsv4b8, B10, B11, B13 And B16, Tsv4h8, H11, H13 And H16.
| Device ID | K072589 |
| 510k Number | K072589 |
| Device Name: | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | William Fisher |
| Correspondent | William Fisher ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-14 |
| Decision Date | 2007-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024019348 | K072589 | 000 |
| 00889024019232 | K072589 | 000 |
| 00889024019249 | K072589 | 000 |
| 00889024019256 | K072589 | 000 |
| 00889024019263 | K072589 | 000 |
| 00889024019300 | K072589 | 000 |
| 00889024019317 | K072589 | 000 |
| 00889024019324 | K072589 | 000 |
| 00889024019331 | K072589 | 000 |
| 00889024019225 | K072589 | 000 |