510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901533Substantially Equivalent

Gdc 588 Casting Alloy

The J.M. Co., Bloomfield CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901533 is the FDA 510(k) clearance record for GDC 588 CASTING ALLOY, a class II device, cleared for The J.M. Co. on under FDA product code EJT (Alloy, Gold-Based Noble Metal). FDA records list one 510(k) clearance for The J.M. Co. As of , FDA records show no recalls naming K901533.

Clearance record

Decision date
Received
(30 days to decision)
Product code
EJT Alloy, Gold-Based Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
The J.M. Co. Ney Industrial Park, Bloomfield CT
Third party review
No

Clearances, product code EJT

Trailing 12 months

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

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