Super Strength Denture Adhesive Cream

Q: What is the product code of K903568?

The FDA product code is KOT – Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium, a Class I (low risk) device regulated under 21 CFR 872.3490.

FDA 510(k) K903568 · Teledyne Getz

Substantially Equivalent

510(k) numberK903568

Submission

Device name: Super Strength Denture Adhesive Cream
Applicant: Teledyne Getz
Elk Grove Village, IL, US
Received: August 7, 1990
Decision date: October 24, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: KOT – Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Device class: Class I (low risk)
Regulation: 21 CFR 872.3490
Specialty: Dental

Other 510(k)s with product code KOT

510(k)	Device	Applicant	Decision
K945462	Super Poli-Grip Denture Adhesive CreamKOT · Traditional	Block Drug Company, Inc.	12/20/1994SE
K941365	Mpi Denture Adhesive Film SealsKOT · Traditional	Medical Polymers, Inc.	04/22/1994SE
K895818	Steadfast Denture Adhesive CreamKOT · Traditional	Stiefel Research Institute, Inc.	04/03/1990SE
K884357	Precision Bioport Collection & Transport SystemKOT · Traditional	Precision Dynamics Corp.	11/01/1988SE
K872225	Super Poli-Grip & Wernet's Denture Adhes. PowderKOT · Traditional	Block Drug Company, Inc.	06/30/1987SE
K854430	Rigident CreamKOT · Traditional	Armkel, LLC	03/04/1986SE
K831493	Denture Adhesive SealsKOT · Traditional	Johnson & Johnson Professionals, Inc.	06/30/1983SE

More from Johnson & Johnson Professionals, Inc.

510(k)	Device	Decision
K923675	Denspro Medium Mint Prophy PasteEJR · Traditional	11/05/1992SE
K923674	Denspro Coarse Mint Prophy PasteEJR · Traditional	11/05/1992SE
K901938	Super Strength Denture Adhesive CreamKOB · Traditional	06/06/1990SE
K901239	Teledyne Getz's Disposable Prophy AngleEFB · Traditional	05/15/1990SE

Questions and answers

When was Super Strength Denture Adhesive Cream cleared by the FDA?

Super Strength Denture Adhesive Cream (K903568) received a 510(k) decision of Substantially Equivalent on October 24, 1990, 78 days after the submission was received.

What is the product code of K903568?

The FDA product code is KOT – Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium, a Class I (low risk) device regulated under 21 CFR 872.3490.