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510(k) Data Aggregation
K Number
K241056Device Name
Light Cure Adhesive
Manufacturer
Sincera Technology (Changchun) Co., Ltd.
Date Cleared
2024-07-16
(89 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Sincera Technology (Changchun) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:
- Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
- Repair of dental restorations of ceramic, composites and/or metal alloys;
- Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
Device Description
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K Number
K240112Device Name
Light Cure Composite
Manufacturer
Sincera Technology (Changchun) Co., Ltd.
Date Cleared
2024-03-15
(59 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Sincera Technology (Changchun) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers
Device Description
Light Cure Composite is a state-of-the-art light-curing, radiopaque, nano-hybrid composite for the restorative therapy. The device cures with light at the wavelength range of 400–500 nm (blue light). The device is paste contained in PP syringe.
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