The following data is part of a premarket notification filed by Tri-stage, Inc. with the FDA for Tri-stage (ts-i) Dental Implant.
| Device ID | K880220 |
| 510k Number | K880220 |
| Device Name: | TRI-STAGE (TS-I) DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | TRI-STAGE, INC. 5897 OBERLIN DR. #205 San Diego, CA 92121 |
| Contact | Michael Klicpera |
| Correspondent | Michael Klicpera TRI-STAGE, INC. 5897 OBERLIN DR. #205 San Diego, CA 92121 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-20 |
| Decision Date | 1988-03-31 |