The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Torque Limiter.
| Device ID | K952120 |
| 510k Number | K952120 |
| Device Name: | TORQUE LIMITER |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Paul Gasser |
| Correspondent | Paul Gasser STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-05 |
| Decision Date | 1995-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TORQUE LIMITER 73206674 1175591 Dead/Cancelled |
Kesselman; David A. 1979-03-09 |