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Solarcry/Temporary Crown & Bridge Mat

by Solar Dental Co., Inc.

510(k) K831294

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831294 Date31 Aug 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBG
Device Class
Class II
Regulation
21 CFR Part 872.3770
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SolarCry Temporary Crown and Bridge Mat is a dental material classified under the product code EBG, designed as a temporary restoration matrix for crowns and bridges. It provides a supportive framework during the fabrication of provisional restorations, ensuring proper contour and alignment before permanent placement.

This device is supplied as a single-use material and is intended for use in dental offices. It is not sterilised but is packaged in a sterile barrier for clinical application. The material is regulated under FDA 510(k) clearance (K831294) with a decision of Substantially Equivalent, falling under the Dental advisory committee classification. No MRI safety or reusable specifications are noted.

Other devices from Solar Dental Co., Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SolarCry Temporary Crown and Bridge Mat used for in a dental setting?

    The SolarCry Temporary Crown and Bridge Mat is designed as a supportive framework to help shape and align provisional crowns and bridges during their fabrication. It ensures the restoration maintains the correct contour and fit before the final, permanent restoration is placed. This makes it ideal for temporary restorations in dental offices.

  • Is the SolarCry Temporary Crown and Bridge Mat reusable or single-use?

    The SolarCry Temporary Crown and Bridge Mat is explicitly supplied as a single-use material. This means each package is intended for one clinical application only, ensuring hygiene and preventing cross-contamination between patients.

  • How is the SolarCry Temporary Crown and Bridge Mat packaged for clinical use?

    The material comes packaged in a sterile barrier, which means it is not pre-sterilized like reusable instruments but is sealed to maintain sterility for its intended single-use application in the dental office. This ensures a clean, uncontaminated surface for temporary restorations.

  • What regulatory pathway does the SolarCry Temporary Crown and Bridge Mat follow?

    The SolarCry Temporary Crown and Bridge Mat is regulated under the FDA 510(k) clearance process, specifically classified under product code EBG (Dental). It received a Substantially Equivalent (SESE) decision from the Dental (DE) Advisory Committee in 1983, confirming its compliance with existing dental restoration standards.