The following data is part of a premarket notification filed by Implant Integration Systems, Inc. with the FDA for Dual Integrator Dental Implant Accessories Parallel Pin, Depth Gage, And Surgical Ratchet.
| Device ID | K970572 |
| 510k Number | K970572 |
| Device Name: | DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INTEGRATION SYSTEMS, INC. 6161 CLARK RD., STE. 8 Paradise, CA 95969 |
| Contact | Cory D Hanosh |
| Correspondent | Cory D Hanosh IMPLANT INTEGRATION SYSTEMS, INC. 6161 CLARK RD., STE. 8 Paradise, CA 95969 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-14 |
| Decision Date | 1998-01-16 |
| Summary: | summary |