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TheraCem

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161256

by Bisco Inc.

Identifiers

510(k) Number
K161256 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)

TheraCem Self-Adhesive Resin Cement is a Dental Cement (FDA classification: Class II) designed for luting dental restorations. It is a dual-cured, self-adhesive resin system that incorporates calcium and fluoride-releasing properties, providing bonding strength to substrates such as zirconia and other indirect restorations like crowns, bridges, inlays, onlays, and posts.

This cement is supplied as a ready-to-use system and is intended for single-use applications in dental settings. It requires no mixing and adheres to various substrates without the need for separate primers or adhesives. The product is regulated under FDA 510(k) clearance (K161256) and falls under the regulation number 872.3275. Sterility and packaging details are not specified in the provided data.

Frequently asked questions

What types of dental restorations is TheraCem Self-Adhesive Resin Cement designed to secure, and why is this important for clinicians?

TheraCem is specifically formulated to lute a variety of dental restorations, including zirconia-based crowns, bridges, inlays, onlays, and posts. This is important for clinicians because it eliminates the need for separate primers or adhesives, simplifying the luting process while ensuring strong bonding to multiple substrate materials. Its dual-cured, self-adhesive properties make it versatile for modern restorative dentistry.

Is TheraCem intended for reuse, or is it meant to be used only once per application? How does this affect its clinical workflow?

TheraCem is explicitly designed for single-use applications in dental settings. This means each package is intended for one procedure, ensuring sterility and consistency in performance. Clinically, this streamlines workflow by reducing the need for mixing or preparation, as it comes ready-to-use, and minimizes cross-contamination risks.

What regulatory pathway was followed for TheraCem’s FDA clearance, and what does this mean for its use in dental practices?

TheraCem received FDA 510(k) clearance (K161256) under the traditional review pathway, classified as a Class II dental cement. This means the device was deemed substantially equivalent to a legally marketed predicate and meets FDA safety and effectiveness requirements. For dental practices, this clearance confirms its compliance with U.S. regulatory standards for dental luting cements.

Does TheraCem require any special storage conditions, and if so, how might this impact its handling in a dental office?

The provided data does not specify sterility or storage instructions for TheraCem, so standard dental office protocols for resin cements should apply. Typically, this would include protection from extreme temperatures, moisture, and direct sunlight. Clinicians should verify the manufacturer’s packaging for any additional guidance to ensure optimal shelf life and performance.

How does TheraCem’s self-adhesive technology differ from traditional luting cements, and what advantages does this offer in clinical practice?

Unlike traditional luting cements that often require separate primers or surface conditioning, TheraCem’s self-adhesive resin system bonds directly to substrates like zirconia and other indirect restorations without additional steps. This simplifies the luting process, reduces chairside time, and ensures consistent adhesion—key advantages for clinicians managing complex restorative cases.

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: TheraCem® Self-Adhesive Resin Cement | BISCO, BISCO THERACEM - moayaddentalsupplies.com, Theracem - BISCO - PDF Catalogs | Technical Documentation, How to Use BISCO's TheraCem® - YouTube

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) K161256 24 fields · synced Sep 19, 2026