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Coltosol F

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031752

by Coltene/Whaledent Inc.

Identifiers

510(k) Number
K031752 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)

Coltosol F is a temporary, eugenol-free filling material that is self-curing under the action of saliva. It is designed for temporary fillings and temporary root canal sealings, available in shade Universal White.

The device is supplied as a dental cement with fluoride-releasing and X-ray opaque properties. It is easy to adapt and adhere in the cavity and requires no mixing. Coltosol F is classified as a Class II device with product code EMA and regulation number 872.3275.

Frequently asked questions

What is Coltosol F used for in dental procedures?

Coltosol F is designed for temporary fillings and temporary root canal sealings. It's a self-curing dental cement that adapts easily to cavities without requiring mixing, making it convenient for temporary dental applications.

Is Coltosol F a single-use or reusable dental material?

Coltosol F is supplied as a dental cement that is intended for single-use applications in dental procedures. It should not be reused or stored for multiple treatments to ensure proper performance and sterility.

What are the key properties of Coltosol F that distinguish it from other temporary filling materials?

Coltosol F is eugenol-free, self-curing under the action of saliva, and features fluoride-releasing and X-ray opaque properties. It's available in Universal White shade and requires no mixing, making it easy to adapt and adhere in the cavity.

How should Coltosol F be stored when not in use?

Coltosol F should be stored according to the manufacturer's instructions to maintain its integrity. As a dental cement, it should be kept in a cool, dry place away from direct sunlight and extreme temperatures to preserve its effectiveness until use.

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: COLTOSOL F by COLTENE/WHALEDENT INC. | FDA 510 (k) Summary, Coltosol F — Coltene/Whaledent SDS & Risk Assessment | ISDSS, Coltosol F (Coltene/Whaledent) - interguidedental.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Coltene/Whaledent Inc.
FDA Applicant
Coltene/Whaledent, Inc.

Sources (1)

  • FDA 510(k) K031752 24 fields · synced Sep 27, 2026