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Resin for Temporary Crown & Bridge

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180657

by Dentis Co. , Ltd

Identifiers

510(k) Number
K180657 FDA 510(k)
FDA Product Code
EBG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a dental restorative material used to fabricate temporary crowns and bridges. It is supplied as a resin formulation designed for intraoral use during the interim period of fixed prosthodontic treatment.

The device is supplied by Dentis Co., Ltd. and is cleared under FDA 510(k) number K180657. It is intended for professional dental use and is regulated under product code EBG. The material is used in clinical settings where temporary restorations are required while permanent prostheses are being fabricated.

Frequently asked questions

What is the Resin for Temporary Crown & Bridge used for?

This dental restorative material is specifically designed to fabricate temporary crowns and bridges during the interim period of fixed prosthodontic treatment, providing a functional restoration while permanent prostheses are being created.

How is the Resin for Temporary Crown & Bridge supplied?

The device is supplied as a resin formulation by Dentis Co., Ltd. and is intended for professional dental use in clinical settings where temporary restorations are required during dental procedures.

What is the regulatory status of this dental resin?

This device is cleared under FDA 510(k) number K180657 with a decision code of SESE (Substantially Equivalent) and is regulated under product code EBG, indicating it meets the necessary regulatory requirements for dental materials.

Is the Resin for Temporary Crown & Bridge single-use or reusable?

The device is designed for intraoral use during the interim period of fixed prosthodontic treatment, but the description does not specify whether it is intended for single-use or multiple applications, which would be determined by the manufacturer's instructions for 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: K180657 - Resin for Temporary Crown & Bridge - Dental, PDF K180657 - Resin for Temporary Crown & Bridge, Resin For Temporary Crown & Bridge 510(k) K180657 - FDA.report, K180657 - Crown And Bridge, Temporary, Resin FDA 510 (k) APPLICATION ..., Resin for Temporary Crown & Bridge — FDA K180657

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dentis Co. , Ltd
FDA Applicant
Dentis Co., Ltd.

Sources (1)

  • FDA 510(k) K180657 24 fields · synced Sep 24, 2026