The following data is part of a premarket notification filed by Sulzer Dental, Inc. with the FDA for 3.75mm And 5.0mm Spline Twist Implant.
| Device ID | K013494 |
| 510k Number | K013494 |
| Device Name: | 3.75MM AND 5.0MM SPLINE TWIST 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 | 2001-10-22 |
| Decision Date | 2002-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024013278 | K013494 | 000 |
| 00889024013261 | K013494 | 000 |
| 00889024013018 | K013494 | 000 |
| 00889024013001 | K013494 | 000 |