Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash

Q: What is the product code of K140481?

The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.

FDA 510(k) K140481 · Colgate-Palmolive Company

Substantially Equivalent

510(k) numberK140481

Submission

Device name: Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash
Applicant: Colgate-Palmolive Company
Piscataway, NJ, US
Received: February 26, 2014
Decision date: June 5, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LBH – Varnish, Cavity
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3260
Specialty: Dental

Other 510(k)s with product code LBH

510(k)	Device	Applicant	Decision
K262243	Profisil FreeLBH · Traditional	Kettenbach GmbH & Co. KG	09/03/2026SE
K253052	Fluoride Varnish (Type A,Type C)LBH · Traditional	Nagy Oral Technology Qinhuangdao Co., Ltd.	06/11/2026SE
K252073	VOCO Profluorid Varnish + BioMinLBH · Traditional	Voco GmbH	05/01/2026SE
K261404	UltraEZLBH · Special	Ultradent Products, Inc.	04/30/2026SE
K260830	APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)LBH · Traditional	Sangi Co., Ltd.	03/18/2026SE
K250714	FluoroDose VarnishLBH · Traditional	Centrix, Inc.	11/21/2025SE
K243777	Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional	Theodent, LLC	05/27/2025SE
K241489	ReminGelLBH · Traditional	Inter-Med, Inc.	01/08/2025SE
K241568	CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional	GreenMark Biomedical, Inc.	01/02/2025SE
K242913	Jasmate® ToothpasteLBH · Traditional	Jasberry Healthcare Private Limited	11/22/2024SE

More from Jasberry Healthcare Private Limited

510(k)	Device	Decision
K103461	Colgate Desensitizing Dental CreamLBH · Traditional	09/13/2011SE
K944886	Colgate Precision Mint Wzxed Dental FlossJES · Traditional	04/27/1995SE
K901955	Periogard(R) PeriopenEFS · Traditional	04/15/1991SE
K883335	Colgate Dental FlossJES · Traditional	08/26/1988SE

Questions and answers

When was Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash cleared by the FDA?

Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash (K140481) received a 510(k) decision of Substantially Equivalent on June 5, 2014, 99 days after the submission was received.

What is the product code of K140481?

The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.