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Smart Print Bio Vitality - A2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260152

by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

Identifiers

510(k) Number
K260152 FDA 510(k)
FDA Product Code
EBF FDA 510(k)
Models / Variants
A2 FDA 510(k)
A3 FDA 510(k)
BL1 FDA 510(k)
B1 FDA 510(k)
A2-HT FDA 510(k)
A3-HT FDA 510(k)
BL1-HT FDA 510(k)
B1-HT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) is a dental resin material designed for tooth shade restoration. Classified under product code EBF as a material for dental applications, it is intended for use in restorative procedures requiring precise color matching to natural dentition. Available in multiple tooth-colored shades, including classical and high-translucency variants, it supports esthetic integration with existing teeth. This device falls under the classification of dental materials, specifically for resin-based restorations.

Supplied as a pre-manufactured resin system, the Smart Print Bio Vitality is intended for single-use in dental restorative procedures. The device is regulated under FDA 510(k) clearance (K260152) and is classified as substantially equivalent to predicate devices. It is distributed in various shade options to accommodate different clinical needs, ensuring compatibility with standard dental workflows. No information regarding sterility or MRI safety is provided in the specifications, and storage conditions are not detailed beyond typical medical device handling.

Frequently asked questions

What is the Smart Print Bio Vitality resin used for in dental procedures?

The Smart Print Bio Vitality resin is designed specifically for tooth shade restoration in dental restorative procedures. It is formulated to match the natural color of existing teeth, ensuring seamless integration and esthetic results. The material is ideal for applications where precise color accuracy is critical, such as fillings, inlays, or other restorative treatments.

How is the Smart Print Bio Vitality resin supplied, and is it single-use?

The Smart Print Bio Vitality resin is supplied as a pre-manufactured resin system in multiple shade options. It is intended for single-use only, adhering to standard dental practice protocols for hygiene and infection control. This ensures each application is performed with a fresh, uncontaminated material.

What shade options are available for the Smart Print Bio Vitality resin?

The Smart Print Bio Vitality resin is available in several tooth-colored shades, including classical variants (A2, A3, BL1, B1) and high-translucency versions (A2-HT, A3-HT, BL1-HT, B1-HT). These options cater to different clinical needs, allowing dentists to select the shade that best matches the patient’s natural dentition for optimal esthetic outcomes.

Is the Smart Print Bio Vitality resin sterile, and what are its storage requirements?

The provided specifications do not explicitly state whether the Smart Print Bio Vitality resin is sterile. For single-use dental materials, it is generally recommended to follow standard medical device storage practices, such as keeping the product in a clean, dry environment away from direct sunlight or extreme temperatures. Always refer to the manufacturer’s instructions for specific storage guidelines.

What regulatory clearance does the Smart Print Bio Vitality resin hold?

The Smart Print Bio Vitality resin holds FDA 510(k) clearance under the classification of dental materials for resin-based restorations. It is classified as substantially equivalent to predicate devices and carries the clearance number K260152. This regulatory pathway ensures it meets established safety and effectiveness standards for dental restorative applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT ..., Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT… - FDA.report, Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

Sources (1)

  • FDA 510(k) K260152 24 fields · synced Oct 5, 2026