510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K142880Substantially Equivalent

DMRC Light Cure Orthodontic Adhesive System

Daville Materials, LLC, San Ramon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K142880 is the FDA 510(k) clearance record for DMRC Light Cure Orthodontic Adhesive System, a class II device, cleared for Daville Materials, LLC on under FDA product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). FDA records list one 510(k) clearance for Daville Materials, LLC. As of , FDA records show no recalls naming K142880.

Clearance record

Decision date
Received
(125 days to decision)
Product code
DYH Adhesive, Bracket And Tooth Conditioner, Resin
Regulation
21 CFR 872.3750
Device class
Class II
Review panel
Dental
Applicant
Daville Materials, LLC 3420 Fostoria Way Suite A-200, San Ramon CA
510(k) summary
Statement
Third party review
No

Clearances, product code DYH

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