510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923644Substantially Equivalent

Dw243-64

Ivoclar USA, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923644 is the FDA 510(k) clearance record for DW243-64, a class II device, cleared for Ivoclar USA, Inc. on under FDA product code EJS (Alloy, Other Noble Metal). FDA records list 11 510(k) clearances for Ivoclar USA, Inc., from to . As of , FDA records show no recalls naming K923644.

Clearance record

Decision date
Received
(106 days to decision)
Product code
EJS Alloy, Other Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
Ivoclar USA, 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