510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860487Substantially Equivalent

Urenamel, Posterior Restorative Material

Cadco Dental Products, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860487 is the FDA 510(k) clearance record for URENAMEL, POSTERIOR RESTORATIVE MATERIAL, a class II device, cleared for Cadco Dental Products, Inc. on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list 2 510(k) clearances for Cadco Dental Products, Inc., from to . As of , FDA records show no recalls naming K860487.

Clearance record

Decision date
Received
(109 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
Cadco Dental Products, Inc. 8894 Regent St., Los Angeles CA
Third party review
No

Clearances, product code EBF

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