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510(k) K091362

Device
CERAMIC PEDATRIC PREFORMED CROWN
Applicant
EZ-PEDO INC
510(k) number
K091362
Product code
ELZ  
Decision
Substantially Equivalent (SESE)
Decision date
2009-06-29
Date received
2009-05-08
Regulation
872.3330
Classification name
Crown, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY FISHER
Address
2350 Professional Dr. Suite 200 Roseville CA US 95661 95661

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ELZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932759TEMPOARY POLYCARBONATE CROWNSSouth American Dental Exporting Corp.1994-07-22
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#

summary

FDA Review#

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