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ZAFIRA® is indicated as a direct and indirect restorative material.

ZAFIRA® Light Curing Composite is intended for:

• Posterior restorations (Class I and II)
• Anterior restorations (Class III and IV)
• Cervical restorations (Class V)
• Restoration of deciduous teeth
• Direct veneers
• Indirect restorations (inlays, onlays, and veneers)

ZAFIRA® Light Curing Gum Composite is intended for reproduction of gingiva in prosthetic restorations including:

• Implant restorations
• Crowns and bridges
• Full or partial prostheses

The Subject device is a viscous solution consisting of methacrylate-based resin, silane agent, filler, photo initiators and pigment stored in a 4.2-gram polypropylene syringe.

The Subject device is used by a dental professional (dentist or dental technician) for the restoration of anterior and posterior teeth and for the reconstruction of individual gum areas either directly in the mouth or during the characterization of indirectly fabricated dental prostheses. The device is not intended to be in contact with dental pulp. Device labeling provides guidance on isolation from pulp.

There are two sub-models of the Subject device ZAFIRA® Light Curing Composite and ZAFIRA® Light Curing Gum Composite.

The Subject device is available in:
• 16 tooth shade colors – (ZAFIRA® Light Curing Composite)
A1, A2, A3, B1, BL and BLX (both Dentin and Enamel shades)
A3.5 (Dentin), B2 (Enamel), Incisal, Opaquer

• 5 gingival/gum shade colors (ZAFIRA® Light Curing Gum Composite)
Brown, Dark Pink Veined, Dark Pink, Light Pink, and Orange Pink

Dental restorations fabricated using the Subject device are one-time use, prescription-only devices.

Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.

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