510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K853698Substantially Equivalent

Scotchprime Ceramic Primer

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

K853698 is the FDA 510(k) clearance record for SCOTCHPRIME CERAMIC PRIMER, a class II device, cleared for 3M Company on under FDA product code EIH (Powder, Porcelain). FDA records list 63 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K853698.

Clearance record

Decision date
Received
(71 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
3M Company Chemolite Blvd. & Washington, Cottae Grove MN
Third party review
No

Clearances, product code EIH

Trailing 12 months
13 clearances under product code EIH in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20262
April 20261
May 20261
June 20263
July 20262
August 20261
September 20260
October 20260