Profast(R)-Denture Adhesive Cream

Q: What is the product code of K930336?

The FDA product code is KGB – Mask, Oxygen, Non-Rebreathing, a Class I (low risk) device regulated under 21 CFR 868.5570.

FDA 510(k) K930336 · Fittydent-Altwirth & Schmitt GmbH

Substantially Equivalent

510(k) numberK930336

Submission

Device name: Profast(R)-Denture Adhesive Cream
Applicant: Fittydent-Altwirth & Schmitt GmbH
Chicago, IL, US
Received: January 22, 1993
Decision date: August 24, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KGB – Mask, Oxygen, Non-Rebreathing
Device class: Class I (low risk)
Regulation: 21 CFR 868.5570
Specialty: Anesthesiology

Other 510(k)s with product code KGB

510(k)	Device	Applicant	Decision
K970688	Pocket RescueKGB · Traditional	Cheen Houng Ent. Co. , Ltd.	09/26/1997SE
K960401	Ultimate SealKGB · Traditional	Hans Rudolph, Inc.	06/20/1996SE
K941336	Combo MaskKGB · Traditional	Gam Industries, Inc.	09/09/1994SE
K935917	Challenge Powder-Free, Hypoallergenic, Synthetic Surgical GlovesKGB · Traditional	Bd Becton Dickinson Vacutainer Systems Preanalytic	02/04/1994SE
K932347	Compact MaskKGB · Traditional	Vital Signs, Inc.	01/10/1994SE
K933583	Nonrebreathing ValveKGB · Traditional	Hans Rudolph, Inc.	01/03/1994SE
K933048	Laerdal(Tm) Pocket Mask, ModificationKGB · Traditional	Laerdal Medical Corp.	12/02/1993SE
K913164	Non Rebreathing MaskKGB · Traditional	Specialty Packaging Producs, Inc.	01/15/1992SE
K883766	Mouth-To-Mask Ventilatory AdjunctKGB · Traditional	Medic One	10/21/1988SE
K790162	Oxygen Mask, Concentration Aerosol MaskKGB · Traditional	Airlife, Inc.	04/20/1979SE

More from Airlife, Inc.

510(k)	Device	Decision
K930335	Profast - Denture Adhesive for Lower JawsKOO · Traditional	02/01/1994SE
K930337	Profast(R)-Denture CleanserEFT · Traditional	09/07/1993SE

Questions and answers

When was Profast(R)-Denture Adhesive Cream cleared by the FDA?

Profast(R)-Denture Adhesive Cream (K930336) received a 510(k) decision of Substantially Equivalent on August 24, 1993, 214 days after the submission was received.

What is the product code of K930336?

The FDA product code is KGB – Mask, Oxygen, Non-Rebreathing, a Class I (low risk) device regulated under 21 CFR 868.5570.