FDA.reportPublic FDA data

510(k) K843742

Device
UNITEK CONVERTIBLE CAP REMOVER TOOL
Applicant
UNITEK CORP.
510(k) number
K843742
Product code
JEX  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-09
Date received
1984-09-25
Regulation
872.4565
Classification name
Plier, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LAWRENCE STEVENS
Address
2724 S. Peck Rd. Monrovia CA US 91016 91016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSUnitek Corp.1992-11-25
K924295DEBRACKETING INSTRUMENTUnitek Corp.1992-11-23
K854088UNITEK LIFT-OFF DEBRACKETING INSTRUMENTUnitex Corp.1985-11-26
K760984ORTHODONTIC INSTRUMENTSAdp Intl., Inc.1976-11-15

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases