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Gilb Model 8010

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011200

by 3m Company

Identifiers

510(k) Number
K011200 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)

The Gilb Model 8010 is a dental cement classified under the product code EMA, designed as a zinc oxide-eugenol compound. It serves as a temporary tooth filling, a base cement for affixing temporary fillings, or a protective layer for dental pulp. This material is also used to secure dental devices such as crowns or bridges to teeth.

This dental cement is supplied as a reusable, non-sterile product intended for use in dental settings. It is regulated under the FDA’s Class II designation with special controls and was granted a 510(k) clearance in 2001. The device adheres to regulatory standards outlined in § 872.3275 for zinc oxide-eugenol cements, ensuring compliance with dental material safety and performance requirements.

Frequently asked questions

What is the Gilb Model 8010 dental cement used for?

The Gilb Model 8010 is a zinc oxide-eugenol compound designed as a temporary tooth filling, a base cement for securing temporary fillings, or a protective layer for dental pulp. It also helps stabilize dental devices like crowns or bridges by adhering them to teeth. This versatile material is commonly used in dental procedures requiring temporary support or protection.

Is the Gilb Model 8010 dental cement sterile or reusable?

The Gilb Model 8010 is supplied as a reusable, non-sterile product. It is intended for use in dental settings where it can be cleaned and reused multiple times, provided proper sterilization protocols are followed between applications. Non-sterile products like this are typically used in controlled environments where contamination risks are managed.

How is the Gilb Model 8010 dental cement regulated in the U.S.?

The Gilb Model 8010 is classified under FDA product code EMA and falls under Class II regulatory designation with special controls. It received 510(k) clearance in 2001, demonstrating its compliance with FDA standards for zinc oxide-eugenol cements, as outlined in § 872.3275. This classification ensures it meets performance and safety requirements for dental materials.

What are the key specifications or forms in which the Gilb Model 8010 is available?

The Gilb Model 8010 is supplied as a reusable powder-liquid kit (typical for zinc oxide-eugenol cements), where the powder and liquid components are mixed to form the cement. While the exact packaging details are not specified, it aligns with standard dental cement formulations. The device is not single-use and is intended for repeated clinical applications in dental offices.

How should the Gilb Model 8010 dental cement be stored?

Since the Gilb Model 8010 is a reusable, non-sterile product, it should be stored in a clean, dry, and sealed container to prevent contamination. The manufacturer recommends following standard dental office protocols for handling reusable materials, including proper cleaning and storage to maintain its efficacy and prevent cross-contamination between uses.

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: GILB, MODEL 8010 by 3M COMPANY | FDA 510 (k) Summary, GILB, MODEL 8010 (K011200) - FDA 510 (k), GILB, MODEL 8010 (K011200) — FDA 510 (k) | Innolitics, PDF K011200 - Gilb, Model 8010

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA 510(k) K011200 24 fields · synced Oct 1, 2026