The following data is part of a premarket notification filed by Florida Diamond Instruments Corp. with the FDA for Sterilized Dental Bit Packaging.
| Device ID | K873698 |
| 510k Number | K873698 |
| Device Name: | STERILIZED DENTAL BIT PACKAGING |
| Classification | Bur, Dental |
| Applicant | FLORIDA DIAMOND INSTRUMENTS CORP. 1429 COLONIAL BLVD. Fort Myers, FL 33907 |
| Contact | Schneider |
| Correspondent | Schneider FLORIDA DIAMOND INSTRUMENTS CORP. 1429 COLONIAL BLVD. Fort Myers, FL 33907 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-14 |
| Decision Date | 1987-12-03 |