Sea-Bond

FDA 510(k) K863375 · Combe, Inc.

Substantially Equivalent

510(k) numberK863375

Submission

Device name
Sea-Bond
Applicant
Combe, Inc.
White Plains, NY, US
Received
September 3, 1986
Decision date
September 19, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KXX – Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
Device class
Class I (low risk)
Regulation
21 CFR 872.3450
Specialty
Dental

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K942203OTC Denture CleanserEFT · Traditional 08/10/1994SE
K925259CFR MonographEFT · Traditional 01/11/1993SE
K780719Fungus Fighter InsolesKYS · Traditional 10/10/1978SE
K770413Cushions, Denture Adhesive, All-DayEHS · Traditional 06/24/1977SE
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Questions and answers

When was Sea-Bond cleared by the FDA?

Sea-Bond (K863375) received a 510(k) decision of Substantially Equivalent on September 19, 1986, 16 days after the submission was received.

What is the product code of K863375?

The FDA product code is KXX – Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer, a Class I (low risk) device regulated under 21 CFR 872.3450.