The following data is part of a premarket notification filed by Sulzer Dental, Inc. with the FDA for Screw Vent Implant; Tapered Screw Vent Implant.
| Device ID | K013227 |
| 510k Number | K013227 |
| Device Name: | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SULZER DENTAL, INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Foster Boop |
| Correspondent | Foster Boop SULZER 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 | 2001-09-27 |
| Decision Date | 2001-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024020108 | K013227 | 000 |
| 00889024020054 | K013227 | 000 |
| 00889024019577 | K013227 | 000 |
| 00889024019515 | K013227 | 000 |
| 00889024019461 | K013227 | 000 |
| 00889024019386 | K013227 | 000 |