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510(k) K942203

Device
OTC DENTURE CLEANSER
Applicant
COMBE, INC.
510(k) number
K942203
Product code
EFT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-10
Date received
1994-05-05
Regulation
872.3520
Classification name
Cleanser, Denture, Over The Counter
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN C PENNISI
Address
1101 Westchester Ave. White Plains NY US 10604 10604

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EFT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080631CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSEROral Health Technologies, LLC2008-05-23
K051342MEDICAL INTERPOROUSBonyf AG2006-06-02
K000996TRUBYTE DENTURE CLEANSER/POLISHING COMPOUNDDentsply Intl.2000-06-16
K930337PROFAST(R)-DENTURE CLEANSERFittydent-Altwirth & Schmitt GmbH1993-09-07
K914257DENTURE PRODUCT XEssential Dental Systems, Inc.1993-01-13
K925259CFR MONOGRAPHCombe, Inc.1993-01-11
K902838DENTURE DYNAMIC'S DENTURE MAGICDenture Dynamic'S, Inc.1990-09-06
K903686ARGILITE 4 GOLD ALLOY FOR PORCELAINArgen Precious Metals, Inc.1990-08-29
K895345ORAD TOOTHBRUSH CLEANEROrad, Inc.1990-03-07
K890043DENTCLEAN CONCENTRATED DENTURE CLEANSERK-P Co.1989-06-07
K890668CLEAN DENTLincoln Park Dental Laboratory1989-04-17
K880068EFFERVESCENT DENTURE CLEANSERPerrigo Co.1988-03-07
K874805TATUNG'S DENTURE CLEANING SOLUTIONTatung Company of America, Inc.1988-02-16
K871785DENTURE CLEANSING TABLETPennex Products Co., Inc.1987-09-11
K854995DENCLENZCreighton Products Corp.1986-05-12

Legacy Summary#

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FDA Review#

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