Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OTC DENTURE CLEANSER

K-Number: K942203 · 1994-08-10

ApplicantCombe, Inc.
Decision Date1994-08-10
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OTC DENTURE CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Combe, Inc.. It received FDA 510(k) clearance on 1994-08-10 under 510(k) number K942203. The device is classified under product code EFT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTC DENTURE CLEANSER?

OTC DENTURE CLEANSER is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is Combe, Inc.. The 510(k) number is K942203.

When did OTC DENTURE CLEANSER receive FDA 510(k) clearance?

OTC DENTURE CLEANSER received FDA 510(k) clearance on 1994-08-10, under 510(k) number K942203.

Who is the listed applicant for OTC DENTURE CLEANSER?

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 OTC DENTURE CLEANSER?

The FDA product code for OTC DENTURE CLEANSER is EFT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K925259CFR MONOGRAPHK863375SEA-BONDK780719FUNGUS FIGHTER INSOLESK770413CUSHIONS, DENTURE ADHESIVE, ALL-DAYK770175SEA-BOND ADHEVISE DENTURE CUSHIONS

Related Devices (Code: EFT)

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.

K080631CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSEROral Health Technologies, LLCK051342MEDICAL INTERPOROUSBonyf AGK000996TRUBYTE DENTURE CLEANSER/POLISHING COMPOUNDDentsply Intl.K930337PROFAST(R)-DENTURE CLEANSERFittydent-Altwirth & Schmitt GmbHK914257DENTURE PRODUCT XEssential Dental Systems, Inc.K925259CFR MONOGRAPHCombe, Inc.

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.

↑