The following data is part of a premarket notification filed by Implant Support Systems, Inc. with the FDA for One System Tapered Titanium Abutments.
| Device ID | K925349 |
| 510k Number | K925349 |
| Device Name: | ONE SYSTEM TAPERED TITANIUM ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
| Contact | Lynn Cuperus |
| Correspondent | Lynn Cuperus IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-07-27 |