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BisCem GI

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032597

by Bisco Inc.

Identifiers

510(k) Number
K032597 FDA 510(k)
FDA Product Code
EMA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

BisCem GI is a dual-cure, radiopaque dental cement classified as a Cement, Dental (OpenFDA). It is designed for luting metal crowns, bridges, inlays, onlays, and posts, including porcelain-fused-to-metal restorations. This self-adhesive resin cement bonds directly to tooth structure and dental restorations, providing a durable and stable restoration interface. Its radiopacity aids in radiographic assessment of luting quality and placement accuracy.

BisCem GI is supplied as a paste/paste formulation in an 8g auto-mix dual-syringe system, ensuring precise dispensing and consistent mixing. The product is intended for single-use per manufacturer guidelines and requires refrigeration; it must reach room temperature before use. Regulated under FDA 510(k) clearance (K032597) as substantially equivalent to predicate devices, it adheres to dental cement standards (regulation number 872.3275). No MRI safety or reusable design specifications are indicated in the data.

Frequently asked questions

What types of dental restorations is BisCem GI specifically designed to lute, and how does its bonding mechanism differ from traditional dental cements?

BisCem GI is designed for luting metal crowns, bridges, inlays, onlays, posts, and porcelain-fused-to-metal restorations. Unlike traditional dental cements, it features a self-adhesive resin formulation that bonds directly to both tooth structure and dental restorations, providing a more durable and stable interface without requiring surface conditioning like etching or priming.

How is BisCem GI supplied, and what storage or handling requirements must be followed before use?

BisCem GI comes as an 8g paste/paste auto-mix dual-syringe system, ensuring precise dispensing and consistent mixing. It requires refrigeration and must reach room temperature before use, as cold temperatures can affect its viscosity and performance.

Is BisCem GI intended for single-use only, and if so, why?

Yes, BisCem GI is manufacturer-guideline single-use only. This is likely due to its dual-cure, radiopaque resin composition, which may degrade or alter properties after mixing, compromising bonding integrity and radiographic clarity for subsequent applications.

What regulatory pathway was followed for BisCem GI’s FDA clearance, and what does this mean for clinicians?

BisCem GI received FDA 510(k) clearance (K032597) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to predicate dental cements. Clinicians can rely on this classification, as it confirms compliance with dental cement standards (regulation 872.3275) and ensures the product meets established safety and effectiveness benchmarks.

Why is BisCem GI described as radiopaque, and how does this feature benefit clinical workflow?

BisCem GI’s radiopacity allows it to be visible on X-rays, enabling clinicians to verify luting quality and restoration placement accuracy post-procedure. This feature reduces the need for additional radiographic checks and helps confirm proper seating of crowns, bridges, or posts during follow-up evaluations.

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: BisCem® Self-Adhesive Resin Cement | BISCO, BISCEM GI by BISCO, INC. | FDA 510 (k) Summary, PDF BisCem®

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bisco Inc.
FDA Applicant
Bisco, Inc.

Sources (1)

  • FDA 510(k) K032597 24 fields · synced Sep 20, 2026