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Dia-X Sil Bite

FDA 510(k)

Class II (US FDA 510(k))

510(k) K254112

by Diadent Group International

Identifiers

510(k) Number
K254112 FDA 510(k)
FDA Product Code
ELW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3660 FDA 510(k)
Regulation Number
872.3660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dia-X Sil Bite is a vinyl polysiloxane (VPS)-based material classified as an impression material for dental bite registration. It is designed to capture precise occlusal relationships, providing accurate records for prosthodontic, orthodontic, and implant procedures by ensuring high dimensional stability and final hardness.

This material is supplied as a reusable dental impression compound, intended for intraoral use in clinical settings. It features a fast setting time and is regulated under FDA 510(k) clearance (K254112) as a Class II device under regulation number 872.3660. No specific sterility or MRI safety information is provided in the data.

Frequently asked questions

What clinical specialties is the Dia-X Sil Bite primarily used for, and how does it support those procedures?

The Dia-X Sil Bite is designed for dental professionals specializing in prosthodontics, orthodontics, and implantology. It captures precise occlusal (bite) relationships, ensuring accurate records for custom prosthetics, orthodontic treatment planning, and implant positioning. Its high dimensional stability and fast setting time make it ideal for creating reliable bite registrations in these specialties.

Is the Dia-X Sil Bite intended for single-use or reusable applications, and how does this affect its clinical workflow?

The Dia-X Sil Bite is explicitly described as a reusable dental impression compound, meaning it can be used multiple times in clinical settings. This design allows for cost-effective workflows, as clinicians can sterilize and reuse the material for subsequent bite registrations, provided they follow proper cleaning and handling protocols.

What type of material is the Dia-X Sil Bite made from, and why is this important for dental applications?

The Dia-X Sil Bite is made from vinyl polysiloxane (VPS), a material known for its accuracy and stability in capturing dental impressions. VPS is favored in dental settings because it provides high precision in bite registration, minimal distortion over time, and a fast setting time—critical for creating reliable records for prosthodontic, orthodontic, and implant procedures.

How is the Dia-X Sil Bite regulated, and what does this mean for clinicians using it?

The Dia-X Sil Bite is classified as a Class II medical device under FDA regulation 872.3660 and holds a 510(k) clearance (K254112). This means it has undergone FDA review to ensure its safety and effectiveness for its intended use as an impression material. Clinicians can rely on its regulatory status as evidence of its compliance with U.S. standards for dental impression materials.

Are there any specific storage requirements or handling instructions for the Dia-X Sil Bite?

While the provided data does not specify exact storage conditions, reusable dental impression compounds like the Dia-X Sil Bite typically require proper cleaning, sterilization, and storage to maintain performance. Clinicians should follow manufacturer guidelines for cleaning (e.g., rinsing with water or using approved disinfectants) and store it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its properties for reuse.

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: Dia-X SIL Impression Material (Bite Registration) - DiaDent, Dia-X Sil Bite Safety Data Sheet (SDS) | DiaDent - Manuals+, PDF Safety Data Sheet - endo-tech-com.3dcartstores.com, Dia-X Sil Bite (K254112) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diadent Group International

Sources (1)

  • FDA 510(k) K254112 24 fields · synced Sep 19, 2026