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2ND Modified Vinylac Press Pack Denture Resin

FDA 510(k)

Class II (US FDA 510(k))

510(k) K874025

by Astron Dental Corp.

Identifiers

510(k) Number
K874025 FDA 510(k)
FDA Product Code
EBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3760 FDA 510(k)
Regulation Number
872.3760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 2nd Modified Vinylac Press Pack Denture Resin is a dental material classified as a denture base resin, designed for fabricating custom denture bases. This press-pack system uses vinyl resin to create durable, well-fitting prosthetic appliances under heat and pressure, ensuring precise adaptation to patient anatomy. It is intended for use in dental laboratories to produce removable partial or complete dentures with improved strength and dimensional stability compared to earlier formulations. The modified version incorporates adjustments to enhance performance characteristics while maintaining compatibility with standard denture fabrication techniques.

This device is supplied as a press-pack system, requiring application in a dental laboratory setting with appropriate equipment, including a press machine and mold. It is not sterile and is intended for single-use per batch, though individual components may be reused if properly cleaned and sterilized per manufacturer instructions. The product is non-MRI-safe and must be handled with standard dental laboratory precautions. Authorized under FDA 510(k) clearance K874025 (Traditional pathway, Substantially Equivalent determination), it adheres to dental regulatory standards for press-pack denture resins, with no additional safety classifications specified.

Frequently asked questions

What is the 2nd Modified Vinylac Press Pack Denture Resin used for?

This resin is specifically designed for dental laboratories to fabricate custom denture bases—both removable partial and complete dentures—using a press-pack system. The modified vinyl resin is processed under heat and pressure to achieve a durable, well-fitting prosthetic that adapts closely to patient anatomy. Its formulation improves upon earlier versions by enhancing strength and dimensional stability while remaining compatible with standard denture fabrication techniques.

How is the 2nd Modified Vinylac Press Pack Denture Resin supplied and used?

The resin is supplied as a press-pack system intended exclusively for use in dental laboratories. It requires specialized equipment, including a press machine and molds, to apply heat and pressure during fabrication. The system is not sterile and is designed for single-use per batch, though individual components may be reused if thoroughly cleaned and sterilized according to the manufacturer’s instructions.

Is the 2nd Modified Vinylac Press Pack Denture Resin safe for MRI procedures?

No, this denture resin is explicitly labeled as non-MRI-safe. If a patient requires MRI imaging, the prosthetic must be removed beforehand to avoid potential interference or safety risks. Always follow standard dental laboratory precautions when handling the material.

Can the 2nd Modified Vinylac Press Pack Denture Resin be reused?

The resin itself is intended for single-use per batch, but individual components of the press-pack system may be reused if they are properly cleaned and sterilized following the manufacturer’s guidelines. Reuse should only occur under controlled laboratory conditions to maintain sterility and performance.

What regulatory clearance does the 2nd Modified Vinylac Press Pack Denture Resin hold?

This device holds FDA 510(k) clearance under the traditional pathway, with a determination of substantial equivalence (SESE) to a predicate device. The clearance number is K874025, and it adheres to dental regulatory standards for press-pack denture resins as classified under product code EBI.

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: 2nd Modified Vinylac Press Pack Denture Resin, 2nd Modified Vinylac Press Pack Denture Resin, 510(k) K874025 — 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN, Modified Vinylac Press Pack Denture Resin - Beudamed, VINYLAC PRESS-PACK DENTURE RESIN (K831269) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Astron Dental Corp.

Sources (1)

  • FDA 510(k) K874025 24 fields · synced Oct 1, 2026