510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012341Substantially Equivalent

Translux Energy

Kulzer GmbH, South Bend IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012341 is the FDA 510(k) clearance record for TRANSLUX ENERGY, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K012341.

Clearance record

Decision date
Received
(37 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Heraeus Kulzer, Inc. 4315 S Lafayette Blvd., South Bend IN
510(k) summary
Summary
Third party review
No

Clearances, product code EBZ

Trailing 12 months
1 clearance under product code EBZ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260