510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041680Substantially Equivalent

Orajel Advanced Tooth Desensitizer

Del Pharmaceuticals, Inc., Uniondale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041680 is the FDA 510(k) clearance record for ORAJEL ADVANCED TOOTH DESENSITIZER, a class II device, cleared for Del Pharmaceuticals, Inc. on under FDA product code KLE (Agent, Tooth Bonding, Resin). FDA records list one 510(k) clearance for Del Pharmaceuticals, Inc. As of , FDA records show no recalls naming K041680.

Clearance record

Decision date
Received
(142 days to decision)
Product code
KLE Agent, Tooth Bonding, Resin
Regulation
21 CFR 872.3200
Device class
Class II
Review panel
Dental
Applicant
Del Pharmaceuticals, Inc. 178 Eab Plz., Po Bx 9357, Uniondale NY
510(k) summary
Statement
Third party review
No

Clearances, product code KLE

Trailing 12 months
8 clearances under product code KLE in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KLE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20261
March 20262
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260