Vitablocs Model VX55-***

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K090644 ↗

FDA Product Code

EIH

Device Class

Class II

Regulation

21 CFR Part 872.6660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K152373 Active Cleared 30 Dec 2015

• What types of dental restorations can the Vitablocs Model VX55-*** be used to fabricate, and how does this differ from traditional composite materials?

  The Vitablocs Model VX55-*** is specifically designed for milling into custom dental restorations such as inlays, onlays, and crowns. Unlike traditional composite materials, which require manual layering and curing, these blocks are pre-formed and require milling equipment to achieve precise, chairside or lab-fabricated restorations. This process ensures high accuracy and consistency in fit, while also providing a durable and aesthetically pleasing result for indirect restorative procedures.

• Is the Vitablocs Model VX55-*** block intended for direct patient use, or is it meant for laboratory or clinic preparation before fitting?

  The Vitablocs Model VX55-*** is supplied as a non-sterile, single-use block intended exclusively for use in dental laboratories or clinics. It requires milling equipment to fabricate restorations, meaning it is not meant for direct patient application. The final restoration must be prepared in a controlled environment before being fitted to a patient.

• Are there multiple sizes or models within the Vitablocs VX55-*** line, and how would I determine which one to select for a specific case?

  The exact sizes or models within the Vitablocs VX55-*** line are not detailed in the provided data, but the series is designed for milling custom restorations. Selection would depend on the specific restoration requirements (e.g., inlay, onlay, or crown size) and the milling equipment’s compatibility. Consulting the manufacturer’s technical documentation or a dental technician would help determine the appropriate block for a given case.

• How should the Vitablocs Model VX55-*** blocks be stored, and what precautions should be taken to maintain their integrity before use?

  Since the Vitablocs Model VX55-*** blocks are non-sterile and single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until use to prevent contamination or degradation of the material. Always follow the manufacturer’s storage guidelines to ensure the blocks retain their milling properties and dimensional accuracy.

• What regulatory pathways does the Vitablocs Model VX55-*** follow, and how does this affect its availability or use in clinical settings?

  The Vitablocs Model VX55-*** is authorized for use in the United States under FDA 510(k) clearance (K090644) and complies with the Medical Device Regulation (MDR). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets safety and performance standards. Clinicians and laboratories can use it with confidence, knowing it adheres to these regulatory requirements, though final use remains within professional dental applications only.