510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992067Substantially Equivalent

Belleglaze

Kerr Dental Materials Center, Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992067 is the FDA 510(k) clearance record for BELLEGLAZE, a class II device, cleared for Kerr Dental Materials Center on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 17 510(k) clearances for Kerr Dental Materials Center, from to . As of , FDA records show no recalls naming K992067.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Kerr Dental Materials Center 1717 W. Collins Ave., Orange CA
510(k) summary
Summary
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