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FDA 510(k)

GRANDIO CORE DUAL CURE

K-Number: K112447 · 2011-11-08

ApplicantVoco GmbH
Decision Date2011-11-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GRANDIO CORE DUAL CURE is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2011-11-08 under 510(k) number K112447. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRANDIO CORE DUAL CURE?

GRANDIO CORE DUAL CURE is a medical device that received FDA 510(k) clearance on 2011-11-08. The listed applicant is Voco GmbH. The 510(k) number is K112447.

When did GRANDIO CORE DUAL CURE receive FDA 510(k) clearance?

GRANDIO CORE DUAL CURE received FDA 510(k) clearance on 2011-11-08, under 510(k) number K112447.

Who is the listed applicant for GRANDIO CORE DUAL CURE?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRANDIO CORE DUAL CURE?

The FDA product code for GRANDIO CORE DUAL CURE is EBF.

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Other records listing Voco GmbH as applicant

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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