510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920560Substantially Equivalent

Dw236-34 Alloy for Porcelain Fused to Metal

Invoclar North America, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920560 is the FDA 510(k) clearance record for DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL, a class II device, cleared for Invoclar North America, Inc. on under FDA product code EJS (Alloy, Other Noble Metal). FDA records list 2 510(k) clearances for Invoclar North America, Inc., from to . As of , FDA records show no recalls naming K920560.

Clearance record

Decision date
Received
(25 days to decision)
Product code
EJS Alloy, Other Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
Invoclar North America, Inc. 175 Pineview Dr., Amherst NY
510(k) summary
Statement
Third party review
No

Clearances, product code EJS

Trailing 12 months

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

FDA records show no clearances under product code EJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJS, 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