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Grandio Disc Multicolor

by VOCO GmbH

510(k) K261357

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) K261357↗

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 · Traditional NumberK261357 Date27 Apr 2026ClearedStatusActive
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  • Withdrawn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)

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 Grandio Disc Multicolor is a dental composite resin disc used for direct restorative procedures in dentistry. It is designed to provide a range of color options for precise shade matching in anterior and posterior restorations, ensuring natural aesthetics and functional durability.

Supplied as a single-use, sterile disc, this product is intended for use in clinical settings by dental professionals. The device is authorized under FDA 510K and MDR regulations, with a product code of EBF. It is supplied in a sterile, ready-to-use format and must be stored according to manufacturer guidelines to maintain integrity.

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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 types of dental restorations can the Grandio Disc Multicolor be used for, and why is the multicolor feature important?

    The Grandio Disc Multicolor is designed for direct restorative procedures in both anterior (front) and posterior (back) teeth. The multicolor feature allows dental professionals to achieve precise shade matching, which is critical for natural-looking restorations. This ensures the final restoration blends seamlessly with the patient’s existing teeth, improving aesthetics while maintaining functional durability.

  • Is the Grandio Disc Multicolor intended for single-use or reusable applications, and how does this affect its clinical use?

    The Grandio Disc Multicolor is supplied as a single-use, sterile disc, which means each disc is intended for one patient application only. This design minimizes cross-contamination risks in clinical settings and ensures sterility, which is essential for maintaining patient safety and hygiene during dental procedures.

  • How should the Grandio Disc Multicolor be stored to ensure it remains effective and intact?

    The Grandio Disc Multicolor must be stored according to the manufacturer’s guidelines to preserve its integrity. Since it is sterile and single-use, it should be kept in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Proper storage ensures the disc remains ready for immediate clinical use without compromising its sterility or performance.

  • What regulatory pathways does the Grandio Disc Multicolor follow, and what does this mean for dental professionals?

    The Grandio Disc Multicolor is authorized under both FDA 510(k) clearance and the EU Medical Device Regulation (MDR). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device (for FDA) and compliance with EU safety and performance standards (for MDR). For dental professionals, this indicates the product meets established regulatory requirements for safety and effectiveness in direct restorative procedures.