510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862590Substantially Equivalent

3M Esthetic Design System (Tints & Masking Agents)

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

K862590 is the FDA 510(k) clearance record for 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS), a class II device, cleared for 3M Company on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 63 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K862590.

Clearance record

Decision date
Received
(15 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
3M Company Chemolite Blvd. & Washington, Cottae Grove MN
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