510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K926165Substantially Equivalent

Ceramco Crowns and Bridges

Asap Dental Lab, Ltd., Newburgh NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926165 is the FDA 510(k) clearance record for CERAMCO CROWNS AND BRIDGES, a class II device, cleared for Asap Dental Lab, Ltd. on under FDA product code EJH (Alloy, Metal, Base). FDA records list one 510(k) clearance for Asap Dental Lab, Ltd. As of , FDA records show no recalls naming K926165.

Clearance record

Decision date
Received
(478 days to decision)
Product code
EJH Alloy, Metal, Base
Regulation
21 CFR 872.3710
Device class
Class II
Review panel
Dental
Applicant
Asap Dental Lab, Ltd. 1067 Union Ave., Newburgh NY
510(k) summary
Statement
Third party review
No

Clearances, product code EJH

Trailing 12 months

FDA records hold no clearances under product code EJH in the trailing twelve months.

FDA records show no clearances under product code EJH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260