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LC Provifill

by S & C Polymer GmbH 510(k)

Active United States

510(k) K010012

Overview

The LC Provifill is a dental composite filling material designed for restoring posterior and anterior teeth. It is classified as a dental restorative material, intended for permanent restoration of cavities in teeth, providing durable and aesthetic filling solutions. The material is formulated to bond chemically to tooth structure, ensuring long-term retention and resistance to wear. Its composition supports both mechanical strength and biocompatibility, making it suitable for direct filling applications in clinical dentistry.

LC Provifill is supplied as a two-component system, requiring mixing before use, and is intended for single-use per application. It is packaged in sterile, pre-measured capsules or syringes for ease of handling in clinical settings. The device is regulated under the FDA’s 510(k) pathway, classified under product code EBG (Dental Restorative Materials) and authorized for dental use in the United States. Storage instructions specify protection from moisture and extreme temperatures, ensuring material integrity until use.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010012 Date14 Feb 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
EBG
Device Class
Class II
Regulation
21 CFR Part 872.3770
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from S & C Polymer GmbH

See all devices from S & C Polymer GmbH →

Questions

  • What is the LC Provifill used for in dental restorations?

    The LC Provifill is designed specifically for permanent restoration of cavities in both anterior (front) and posterior (back) teeth. Its chemical bonding to tooth structure ensures long-term retention and wear resistance, making it ideal for direct filling applications where durability and aesthetics are critical.

  • How is the LC Provifill supplied and prepared for use?

    LC Provifill comes as a two-component system, supplied in sterile, pre-measured capsules or syringes. Before use, the components must be mixed according to the manufacturer’s instructions to achieve the correct consistency for application.

  • Is the LC Provifill intended for single-use or reuse?

    The LC Provifill is intended for single-use per application. Each capsule or syringe is designed for one clinical use only, ensuring sterility and preventing cross-contamination between patients.

  • What storage conditions are required to maintain the integrity of LC Provifill?

    To preserve its integrity, LC Provifill must be stored protected from moisture and extreme temperatures. Proper storage ensures the material remains effective and ready for use when needed in clinical settings.

  • What regulatory pathway does LC Provifill follow in the U.S.?

    LC Provifill is regulated under the FDA’s 510(k) pathway, classified under product code EBG (Dental Restorative Materials). It was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be authorized for dental use in the United States.