ORAJEL ADVANCED TOOTH DESENSITIZER— 510(k) K041680

Name: FDA 510(k) clearance K041680
Creator: U.S. Food and Drug Administration
Published: 2004-11-10

Substantially Equivalent

Del Pharmaceuticals, Inc.

FDA 510(k) clearance K041680 for ORAJEL ADVANCED TOOTH DESENSITIZER, Substantially Equivalent on 2004-11-10. Applicant: Del Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: Del Pharmaceuticals, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2004-06-21
Decision date: 2004-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uniondale, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

view all

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.