Denture Adhesive Seals

Q: What is the product code of K831493?

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) K831493 · Johnson & Johnson Professionals, Inc.

Substantially Equivalent

510(k) numberK831493

Submission

Device name: Denture Adhesive Seals
Applicant: Johnson & Johnson Professionals, Inc.
Raynham, MA, US
Received: May 10, 1983
Decision date: June 30, 1983
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
K903568	Super Strength Denture Adhesive CreamKOT · Traditional	Teledyne Getz	10/24/1990SE
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

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Questions and answers

When was Denture Adhesive Seals cleared by the FDA?

Denture Adhesive Seals (K831493) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 51 days after the submission was received.

What is the product code of K831493?

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.