510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K875344Substantially Equivalent

Heraeus' Heragam 48, Non Gamma 2 Den. Amal. Alloy

Kulzer GmbH, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875344 is the FDA 510(k) clearance record for HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY, a class II device, cleared for Kulzer, Inc. on under FDA product code EJJ (Alloy, Amalgam). FDA records list 205 510(k) clearances for Kulzer, Inc., from to . As of , FDA records show no recalls naming K875344.

Clearance record

Decision date
Received
(79 days to decision)
Product code
EJJ Alloy, Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Kulzer, Inc. 111 N. Wabash Ave., Chicago IL
Third party review
No

Clearances, product code EJJ

Trailing 12 months

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

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