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FDA 510(k)

CUSHIONS, DENTURE ADHESIVE, ALL-DAY

K-Number: K770413 · 1977-06-24

ApplicantCombe, Inc.
Decision Date1977-06-24
Product CodeEHS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CUSHIONS, DENTURE ADHESIVE, ALL-DAY is the device name listed in this FDA 510(k) record. The listed applicant is Combe, Inc.. It received FDA 510(k) clearance on 1977-06-24 under 510(k) number K770413. The device is classified under product code EHS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSHIONS, DENTURE ADHESIVE, ALL-DAY?

CUSHIONS, DENTURE ADHESIVE, ALL-DAY is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Combe, Inc.. The 510(k) number is K770413.

When did CUSHIONS, DENTURE ADHESIVE, ALL-DAY receive FDA 510(k) clearance?

CUSHIONS, DENTURE ADHESIVE, ALL-DAY received FDA 510(k) clearance on 1977-06-24, under 510(k) number K770413.

Who is the listed applicant for CUSHIONS, DENTURE ADHESIVE, ALL-DAY?

The FDA 510(k) record lists Combe, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSHIONS, DENTURE ADHESIVE, ALL-DAY?

The FDA product code for CUSHIONS, DENTURE ADHESIVE, ALL-DAY is EHS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Combe, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942203OTC DENTURE CLEANSERK925259CFR MONOGRAPHK863375SEA-BONDK780719FUNGUS FIGHTER INSOLESK770175SEA-BOND ADHEVISE DENTURE CUSHIONS

Related Devices (Code: EHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971002SMILE WITH CONFIDENCELloyd V. ZiemendorfK813190SOFT PLATE CUSHIONLeonard Russo Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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