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510(k) K833736

Device
GOLD-PALLADIUM-SILVER BASED CAST/ALLOY
Applicant
JENERIC IND.
510(k) number
K833736
Product code
EIS  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-29
Date received
1983-10-25
Regulation
872.4565
Classification name
Remover, Crown
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992649ATD AUTOMATIC BRIDGE REMOVERJ. Morita USA, Inc.1999-10-29
K951299EASY PNEUMATIC CROWN AND BRIDGE REMOVERDentco, Inc.1995-08-29
K863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARPacific Union Dental, Inc.1986-09-22
K854795HAZELTON TEMPORARY CROWN AND BRIDGE REMOVERFran Hazelton Co.1986-03-04
K842026H-TYPE BRIDGE REMOVERHiga Manufacturing , Ltd.1984-07-11
K833287SATIN CAST ECONOCASTGenesis Industries, Inc.1984-01-03
K833290C & B 40 PENTRO C & B40Genesis Industries, Inc.1984-01-03
K833278C & B 45Genesis Industries, Inc.1983-12-29
K833289C & B 61 PENTRON C & B61Genesis Industries, Inc.1983-12-29
K833280SUPRA AP CHOICE 83Genesis Industries, Inc.1983-12-26
K833285RX IV PENTRON IVGenesis Industries, Inc.1983-12-22
K833288C & B57 PENTRON C & B57Genesis Industries, Inc.1983-12-20
K833286RX SEG ECONOPLUSGenesis Industries, Inc.1983-11-28
K833284RX 41 PENTRON 41Genesis Industries, Inc.1983-11-28
K833283RX ORY PENTRON C & BGenesis Industries, Inc.1983-11-28

Legacy Summary#

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FDA Review#

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