The following data is part of a premarket notification filed by Almore Intl., Inc. with the FDA for Diamonds Burs-composit Finishing.
Device ID | K854690 |
510k Number | K854690 |
Device Name: | DIAMONDS BURS-COMPOSIT FINISHING |
Classification | Bur, Dental |
Applicant | ALMORE INTL., INC. POST OFFICE BOX 25214 Portland, OR 97225 |
Contact | Morin |
Correspondent | Morin ALMORE INTL., INC. POST OFFICE BOX 25214 Portland, OR 97225 |
Product Code | EJL |
CFR Regulation Number | 872.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-21 |
Decision Date | 1986-03-25 |