510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191103Substantially Equivalent

Parkell Desensitizer Gel

Parkell, Inc., Edgewood NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191103 is the FDA 510(k) clearance record for Parkell Desensitizer Gel, a class II device, cleared for Parkell, Inc. on under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list 61 510(k) clearances for Parkell, Inc., from to . As of , FDA records show no recalls naming K191103.

Clearance record

Decision date
Received
(211 days to decision)
Product code
EJK Liner, Cavity, Calcium Hydroxide
Regulation
21 CFR 872.3250
Device class
Class II
Review panel
Dental
Applicant
Parkell, Inc. 300 Executive Dr., Edgewood NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJK

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