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Restorative System Profile

by The S. S. White Co. 510(k)

Active United States

510(k) K781293

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781293 Date18 Aug 1978ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Restorative System Profile is a dental device classified under the product code EBF, designed for dental restorative procedures. It is intended for use in filling and restoring teeth by providing a durable, biocompatible material for cavity preparation and filling applications, ensuring long-term dental integrity.

This system is supplied as a reusable dental instrument kit, intended for use in clinical dental settings. It is not described as sterile or single-use in the regulatory data. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of August 18, 1978, and is regulated under the Dental advisory committee. No additional specifications regarding MRI safety, storage, or size variations are provided in the available data.

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