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510(k) Data Aggregation
K Number
K060860Device Name
TURKOM-CERA
Manufacturer
Date Cleared
2006-05-19
(51 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTAL SUPPLIERS OF AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Turkom-Cera fused alumina copings are indicated for use as core structures of an artificial prosthesis, i.e., a three unit bridge, long bridges, full mouth bridges, for partially endentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
The copings are also indicated for use as single crowns that will be cemented to a natural or an artificial tooth abutment in the treatment of partially endentulous patients in order to restore chewing function.
Device Description
Turkom-Cera (Coping for porcelain teeth)
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