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510(k) K003517

Device
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
Applicant
OTRES, LLC.
510(k) number
K003517
Product code
MCF  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-06
Date received
2000-11-14
Regulation
872.6855
Classification name
Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID BUDDINGH
Address
4225 Naperville Rd. Suite 155 Lisle IL US 60542 60542

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023662PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZERHwadong International Company , Ltd.2003-05-28
K021258GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZERGerm Terminator Corporation2002-05-10
K901459DS60 TOOTHBRUSH SANITIZERAssociated Mills, Inc.1990-09-17
K896481PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZERPurebrush Assoc.1990-05-15

Legacy Summary#

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FDA Review#

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