510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K911061Substantially Equivalent

Espe Ketac-Endo Aplicap

H.A. Opotow Consulting, Lake Worth FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911061 is the FDA 510(k) clearance record for ESPE KETAC-ENDO APLICAP, a class II device, cleared for H.A. Opotow Consulting on under FDA product code EMA (Cement, Dental). FDA records list one 510(k) clearance for H.A. Opotow Consulting. As of , FDA records show no recalls naming K911061.

Clearance record

Decision date
Received
(298 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
H.A. Opotow Consulting 200 Lake Ave., Lake Worth FL
Third party review
No

Clearances, product code EMA

Trailing 12 months
10 clearances under product code EMA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EMA, trailing twelve months
MonthClearances
November 20250
December 20253
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20261
August 20262
September 20261
October 20260