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510(k) K954971

Device
ACETAL DENTAL/PREFORMED CLASP
Applicant
B & H TECHNICAL SERVICES LTD.
510(k) number
K954971
Product code
EHP  
Decision
Substantially Equivalent (SESE)
Decision date
1995-12-11
Date received
1995-10-27
Regulation
872.3285
Classification name
Clasp, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND CHINEA
Address
2020 124th Ave., NE Suite C-106 Bellevue WA US 98005 98005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EHP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022032ACETALInovativ, LLC2002-08-29
K983558ACETAL DENTAL/PREFORMED CLASPDentamax, Inc.1999-01-07
K974622DENTAL DMicro Dental Laboratories1998-02-10
K955946ACETAL DENTAL/PREFORMED CLASPPressing DI Monticelli Rag. Stefano1995-12-11
K854765INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETHC&C Systems, Inc.1986-06-13
K800574VACUDENT LUMIX 65Vacudent Sales Corp.1980-05-20
K800575VACUDENT LUMIX 70Vacudent Sales Corp.1980-05-20

Legacy Summary#

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FDA Review#

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