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510(k) K935561

Device
INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
Applicant
BAUSCH & LOMB, INC.
510(k) number
K935561
Product code
JEQ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-26
Date received
1993-11-17
Regulation
872.6865
Classification name
Toothbrush, Powered
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SYDNEY LILLY
Address
5243 Royal Woods Pkwy., #100 Tucker GA US 30084 30084

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JEQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200881Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble Company2020-08-27
K141018ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KITProcter & Gamble Co.2014-09-15
K061351ORAL-B SONIC COMPLETEBraun GmbH2006-06-05
K061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIESBraun GmbH2006-05-31
K040416SONICARE ADVANCE TOOTHBRUSH, MODEL 4900Philips Oral Healthcare, Inc.2004-07-02
K022900BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHESJohn O. Butler Co.2002-11-14
K012914SONICWAVE SONIC PLAQUE REMOVERHomedics, Inc.2001-10-01
K970381POWERED TOOTHBRUSHEmjoi Action USA, Ltd.1997-04-18
K943942TRAV-LER KITJohn O. Butler Co.1995-03-08
K945248HUKUBA HYG ELECTRIC IONIC TOOTHBRUSHHukuba Dental Corp.1995-01-26
K944084JENERIC/PENTRON P0WERED TOOTHBRUSTJeneric/Pentron, Inc.1994-12-20
K942634PEMBUSHCrossroads Trading Co.1994-09-02
K941209MY BEAT POWERED TOOTHBRUSHSanwa Components USA, Inc.1994-06-16
K941243ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSHOraline, Ltd.1994-06-06
K940288WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENTTeledyne Water Pik1994-05-26

Legacy Summary#

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FDA Review#

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