510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923549Substantially Equivalent

Paladisc Lc

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

K923549 is the FDA 510(k) clearance record for PALADISC LC, a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code EBH (Material, Impression Tray, Resin). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K923549.

Clearance record

Decision date
Received
(75 days to decision)
Product code
EBH Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Applicant
Heraeus Kulzer, Inc. 10005 Muirlands Blvd., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code EBH

Trailing 12 months

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

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