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510(k) K081273

Device
ULTRACAPS S
Applicant
SDI LTD.
510(k) number
K081273
Product code
OIV  
Decision
Substantially Equivalent (SESE)
Decision date
2008-07-10
Date received
2008-05-05
Regulation
872.3070
Classification name
Dental Amalgam
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RAY CAHILL
Address
5-9 Brunsdon St. Bayswater, Victoria AU 3153 3153

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K140125NEW STETIC DENTAL AMALGAM ALLOYNew Stetic2014-04-29

Legacy Summary#

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FDA Review#

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