The following data is part of a premarket notification filed by Surgical Precision Instruments, Corp. with the FDA for Tin Coated Dental Burs.
| Device ID | K911208 |
| 510k Number | K911208 |
| Device Name: | TIN COATED DENTAL BURS |
| Classification | Bur, Dental |
| Applicant | SURGICAL PRECISION INSTRUMENTS, CORP. 64 CHAPMAN DR. Barrington, NH 03825 |
| Contact | Larry Rogers |
| Correspondent | Larry Rogers SURGICAL PRECISION INSTRUMENTS, CORP. 64 CHAPMAN DR. Barrington, NH 03825 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-19 |
| Decision Date | 1991-09-16 |