510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810813Substantially Equivalent

Dmg-Polishable Composite

Dental-Material Gesellschaft, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810813 is the FDA 510(k) clearance record for DMG-POLISHABLE COMPOSITE, a class II device, cleared for Dental-Material Gesellschaft on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 2 510(k) clearances for Dental-Material Gesellschaft. As of , FDA records show no recalls naming K810813.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Dental-Material Gesellschaft 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EBD

Trailing 12 months
1 clearance under product code EBD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260