The following data is part of a premarket notification filed by Drm Research Laboratories, Inc. with the FDA for Zti Implants System, Drm Implants.
| Device ID | K034067 |
| 510k Number | K034067 |
| Device Name: | ZTI IMPLANTS SYSTEM, DRM IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DRM RESEARCH LABORATORIES, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Samuel Waknine |
| Correspondent | Samuel Waknine DRM RESEARCH LABORATORIES, INC. 29 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-31 |
| Decision Date | 2004-03-08 |
| Summary: | summary |