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510(k) K140125

Device
NEW STETIC DENTAL AMALGAM ALLOY
Applicant
NEW STETIC
510(k) number
K140125
Product code
OIV  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-29
Date received
2014-01-16
Regulation
872.3070
Classification name
Dental Amalgam
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN O'BRIEN
Address
445 Apollo Beach Blvd. Apollo Beach FL US 33572 33572

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OIV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223182Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 AlloyWorldwork S.R.L2023-05-01
K081273ULTRACAPS SSdi , Ltd.2008-07-10

Legacy Summary#

summary

FDA Review#

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