The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Bio-esthetic Indirect Abutment.
| Device ID | K970073 |
| 510k Number | K970073 |
| Device Name: | BIO-ESTHETIC INDIRECT ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Jeff Hausheer, Ph.d. |
| Correspondent | Jeff Hausheer, Ph.d. STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-08 |
| Decision Date | 1997-07-03 |
| Summary: | summary |