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510(k) K863500

Device
STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
Applicant
PACIFIC UNION DENTAL, INC.
510(k) number
K863500
Product code
EIS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-22
Date received
1986-09-09
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#

Contact
KENNETH WOO
Address
P.O. Box 2025 Silver Spring MD US 20902 20902

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
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
K833736GOLD-PALLADIUM-SILVER BASED CAST/ALLOYJeneric Ind.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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