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510(k) Data Aggregation
K Number
K123613Device Name
SYNSPAR ADVANCED
Manufacturer
Date Cleared
2013-02-20
(89 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
ARDENT INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Synspar Advance Pressable Ceramic (Pellets) is a leucite ceramic system for:
Press-on-Metal Restorations
- Single unit fully anatomical crowns in the anterior and posterior regions
- Fully anatomical splinted crowns and bridges in the anterior and posterior regions
- Compatible with dental alloys in the CTE range 13.6-14.6 x 10°/K (25-500°C). Alloys should be copper-free and contain less than 14% silver.
Pressed All-ceramic Restorations
- Adhesively cemented single unit anterior all-ceramic restorations (crowns, inlays, onlays, veneers)
Device Description
Synspar Advance Pressable Ceramic (Pellets) is a dental porcelain system composed of a leucite-ceramic which utilizes a press-on or conventional heat-pressing technique for dental restoration fabrication.
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