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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Amalgam
510(k) Number K081273
Device Name ULTRACAPS S
Applicant
Sdi , Ltd.
5-9 Brunsdon St.
Bayswater, Victoria,  AU 3153
Applicant Contact RAY CAHILL
Correspondent
Sdi , Ltd.
5-9 Brunsdon St.
Bayswater, Victoria,  AU 3153
Correspondent Contact RAY CAHILL
Regulation Number872.3070
Classification Product Code
OIV  
Subsequent Product Codes
EJJ   ELY  
Date Received05/05/2008
Decision Date 07/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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