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510(k) Data Aggregation
K Number
K051717Device Name
RN SYNOCTA TEMPORARY MESO ABUTMENT
Manufacturer
INSTITUT STRAUMANN SA
Date Cleared
2005-07-07
(10 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
INSTITUT STRAUMANN SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants for temporary restoration of single crowns in the anterior and posterior region for use up to six months.
Device Description
Description of these Abutment is a temporary abutment made of medical grade plastic structure for immediate temporization by the clinician. This can be customized by the clinician and serves as a base for direct veneering or cemented restoration. The abutment is strengthened by an inlay of Titanium alloy that fits precisely into the Straumann Regular Neck (RN) implants.
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K Number
K003552Device Name
ITI DENTAL IMPLANT SYSTEM
Manufacturer
INSTITUT STRAUMANN SA
Date Cleared
2001-08-17
(273 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
INSTITUT STRAUMANN SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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