The following data is part of a premarket notification filed by Dental-material Gesellschaft with the FDA for Dmg-polishable Composite.
Device ID | K810813 |
510k Number | K810813 |
Device Name: | DMG-POLISHABLE COMPOSITE |
Classification | Coating, Filling Material, Resin |
Applicant | DENTAL-MATERIAL GESELLSCHAFT 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-24 |
Decision Date | 1981-04-14 |