Cushions, Denture Adhesive, All-Day

FDA 510(k) K770413 · Combe, Inc.

Substantially Equivalent

510(k) numberK770413

Submission

Device name
Cushions, Denture Adhesive, All-Day
Applicant
Combe, Inc.
Mchenry, IL, US
Received
March 4, 1977
Decision date
June 24, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EHS – Cushion, Denture, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3540
Specialty
Dental

Other 510(k)s with product code EHS

510(k)DeviceApplicantDecision
K971002Smile with ConfidenceEHS · Traditional Lloyd V. Ziemendorf07/15/1997SE
K813190Soft Plate CushionEHS · Traditional Leonard Russo Co.02/05/1982SE

More from Leonard Russo Co.

510(k)DeviceDecision
K171855External Moisturizing GelNUC · Special 07/21/2017SE
K150615Vaginal Moisturizing GelNUC · Traditional 05/01/2015SE
K141718Internal Hydrating GelNUC · Traditional 11/13/2014SE
K942203OTC Denture CleanserEFT · Traditional 08/10/1994SE
K925259CFR MonographEFT · Traditional 01/11/1993SE
K863375Sea-BondKXX · Traditional 09/19/1986SE
K780719Fungus Fighter InsolesKYS · Traditional 10/10/1978SE
K770175Sea-Bond Adhevise Denture CushionsKKX · Traditional 02/04/1977SE

Questions and answers

When was Cushions, Denture Adhesive, All-Day cleared by the FDA?

Cushions, Denture Adhesive, All-Day (K770413) received a 510(k) decision of Substantially Equivalent on June 24, 1977, 112 days after the submission was received.

What is the product code of K770413?

The FDA product code is EHS – Cushion, Denture, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 872.3540.