FDA.reportPublic FDA data

510(k) K771128

Device
NEKO CERAMIC CONVENIENCE CROWNS
Applicant
Sterndent Corp.
510(k) number
K771128
Product code
ELZ
Decision
Substantially Equivalent (SESE)
Decision date
1977-07-15
Date received
1977-06-23
Regulation
872.3330
Classification name
Crown, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
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
K770684CROWN, ACRYLIC, CORAL BRAND, PREFORMEDParker Laboratories, Inc.1977-04-26