510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844211Substantially Equivalent

Concise Light Cured White Sealant

3M Company, Cottae Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844211 is the FDA 510(k) clearance record for CONCISE LIGHT CURED WHITE SEALANT, a class II device, cleared for 3M Company on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 63 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K844211.

Clearance record

Decision date
Received
(68 days to decision)
Product code
EBC Sealant, Pit And Fissure, And Conditioner
Regulation
21 CFR 872.3765
Device class
Class II
Review panel
Dental
Applicant
3M Company Chemolite Blvd. & Washington, Cottae Grove MN
Third party review
No

Clearances, product code EBC

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