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510(k) K924645

Device
TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS
Applicant
UNITEK CORP.
510(k) number
K924645
Product code
JEX  
Decision
Substantially Equivalent (SESE)
Decision date
1992-11-25
Date received
1992-09-14
Regulation
872.4565
Classification name
Plier, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARLYN SCHEFF
Address
2724 S. Peck Rd. Monrovia CA US 91016 91016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JEX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955242TITANIUM BIRD BEAK PLIERSybron Dental Specialties, Inc.1995-12-01
K935141DENTAURUM PLIERSDentauraum, Inc.1994-01-31
K924295DEBRACKETING INSTRUMENTUnitek Corp.1992-11-23
K854088UNITEK LIFT-OFF DEBRACKETING INSTRUMENTUnitex Corp.1985-11-26
K843742UNITEK CONVERTIBLE CAP REMOVER TOOLUnitek Corp.1984-11-09
K760984ORTHODONTIC INSTRUMENTSAdp Intl., Inc.1976-11-15

Legacy Summary#

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FDA Review#

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