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Rebilda DC Modification

by VOCO GmbH

510(k) K060893

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060893↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK060893 Date25 May 2006ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Modification to Rebilda Dc
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, 18 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 Rebilda DC Modification is a dental device classified under the product code EBF for dental restorative materials. It is designed as a modification to an existing dental composite system, intended for use in direct restorative procedures to repair and restore tooth structure with high precision and durability.

This modification is supplied as a dental-grade material, intended for single-use applications in clinical settings. It is authorized under FDA 510K and MDR, with a clearance type designated as Special for dental modifications. The device is supplied in sterile form and must be handled according to standard dental practice protocols to ensure proper application and patient safety.

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Questions

AI-generated answers, 18 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 Rebilda DC Modification specifically used for in dental procedures?

    The Rebilda DC Modification is a dental composite material designed for direct restorative procedures. It is intended to repair and restore damaged tooth structure with high precision and durability, filling cavities or repairing existing restorations while maintaining the integrity of the natural tooth.

  • Is the Rebilda DC Modification meant for single-use or can it be reused?

    The Rebilda DC Modification is explicitly supplied for single-use applications in clinical settings. This ensures patient safety and sterility, aligning with standard dental practice protocols for composite materials.

  • How is the Rebilda DC Modification packaged and stored?

    The device is supplied in a sterile form, which means it is pre-sterilized and ready for immediate clinical use. Proper storage should follow standard dental protocols to maintain sterility until use, as with other dental-grade materials.

  • What regulatory pathways does the Rebilda DC Modification follow?

    The Rebilda DC Modification is authorized under both FDA 510K and MDR (Medical Device Regulation) frameworks. Its clearance type is designated as 'Special,' reflecting its status as a modification to an existing dental composite system, ensuring compliance with both U.S. and EU regulatory standards.