510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920425Substantially Equivalent

3M Brand Restorative Z100

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

K920425 is the FDA 510(k) clearance record for 3M BRAND RESTORATIVE Z100, a class II device, cleared for 3M Company on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 146 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K920425.

Clearance record

Decision date
Received
(46 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
3M Company 3m Center, St. Paul MN
510(k) summary
Statement
Third party review
No

Clearances, product code EBF

Trailing 12 months
18 clearances under product code EBF in the twelve months to November 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code EBF, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20262
April 20265
May 20262
June 20262
July 20262
August 20261
September 20262
October 20260
November 20260