The following data is part of a premarket notification filed by Innovators, Inc. with the FDA for Silicont Bur Block.
| Device ID | K921406 |
| 510k Number | K921406 |
| Device Name: | SILICONT BUR BLOCK |
| Classification | Bur, Dental |
| Applicant | INNOVATORS, INC. 2721 D INDUSTRIAL DR. Jefferson City, MO 65109 -0771 |
| Contact | Don Gentry |
| Correspondent | Don Gentry INNOVATORS, INC. 2721 D INDUSTRIAL DR. Jefferson City, MO 65109 -0771 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-20 |
| Decision Date | 1992-04-28 |