510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915095Substantially Equivalent

Estiseal Lc

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

K915095 is the FDA 510(k) clearance record for ESTISEAL LC, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K915095.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EBC Sealant, Pit And Fissure, And Conditioner
Regulation
21 CFR 872.3765
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 EBC

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