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510(k) K932759

Device
TEMPOARY POLYCARBONATE CROWNS
Applicant
SOUTH AMERICAN DENTAL EXPORTING CORP.
510(k) number
K932759
Product code
ELZ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-22
Date received
1993-06-08
Regulation
872.3330
Classification name
Crown, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LOPEZ
Address
1058 E. 33rd St. Hialeah FL US 33013 33013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091362CERAMIC PEDATRIC PREFORMED CROWNEz-Pedo, Inc.2009-06-29
K931352PEDO JACKETS OR PJ'SGeorge M. Wilson, Dds1993-07-21
K913152WHITER BITER CROWNGeorge M. Wilson, Dds1991-09-30
K912686WHITER BITER CROWNGeorge M. Wilson, Dds1991-09-16
K892893SDI POLYCARBONATE CROWN, SCHEIN'SSvenska Dental Instruments AB1989-06-06
K883325PERFORMED CROWN (STAINLESS STEEL)Whitecap Dental Co.1988-09-16
K771128NEKO CERAMIC CONVENIENCE CROWNSSterndent Corp.1977-07-15
K770684CROWN, ACRYLIC, CORAL BRAND, PREFORMEDParker Laboratories, Inc.1977-04-26

Legacy Summary#

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FDA Review#

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