The following data is part of a premarket notification filed by Tri-stage, Inc. with the FDA for Dental Burs.
| Device ID | K882183 |
| 510k Number | K882183 |
| Device Name: | DENTAL BURS |
| Classification | Bur, Dental |
| Applicant | TRI-STAGE, INC. 5897 OBERLIN DR. #205 San Diego, CA 92121 |
| Contact | Alan Donald |
| Correspondent | Alan Donald TRI-STAGE, INC. 5897 OBERLIN DR. #205 San Diego, CA 92121 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-24 |
| Decision Date | 1988-06-21 |