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510(k) K892264

Device
ORALCHEK SUPER-SOFT BRUSH
Applicant
PFIZER, INC.
510(k) number
K892264
Product code
EFW  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-14
Date received
1989-04-05
Regulation
872.6855
Classification name
Toothbrush, Manual
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID C OPPENHEIMER
Address
235 E. 42nd St. Ny NY US 10017 10017

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EFW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130186DENTEK EASY BRUSH WITH FLUORIDEDen Tek Oral Care, Inc.2013-07-15
K121165BEAM BRUSH/BEAM APPBeam Technologies, LLC2012-06-21
K102871SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.2011-10-03
K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSHProcter & Gamble2008-02-06
K021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIALAgion Technologies, LLC2002-07-17
K020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTSCoronet Group North America, LLC2002-06-03
K000290LAZERSMILE, LAZERWHITEBiolase Technology, Inc.2000-04-14
K994144TOOTHBRUSH WASHCal Huech, Inc.2000-03-02
K992435BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZERAzo Enterprises1999-10-15
K980995PLAQ-ATAQ-IEthicare1998-08-20
K974761BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSHJohn O. Butler Co.1998-06-16
K973236CREST TOOTHBRUSH WITH MICROSHIELDProcter & Gamble Co.1998-03-11
K971589REACH ANTIBACTERIAL TOOTHBRUSHPersonal Products Co.1997-07-24
K955530RANIR HI-TECHNOLOGY DENTAL FLOSSRanir/Dcp Corp.1995-12-28
K950993BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSHJohn O. Butler1995-06-02

Legacy Summary#

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FDA Review#

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