510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924422Substantially Equivalent

Palabond

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

K924422 is the FDA 510(k) clearance record for PALABOND, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K924422.

Clearance record

Decision date
Received
(64 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Heraeus Kulzer, Inc. 10005 Muirlands Blvd., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code EBI

Trailing 12 months
7 clearances under product code EBI in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260
November 20260