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FDA 510(k)

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE

K-Number: K101540 · 2010-10-29

ApplicantNovocol Inc. Dba Septodont and Confi-Dental Produc
Decision Date2010-10-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE is the device name listed in this FDA 510(k) record. The listed applicant is Novocol Inc. Dba Septodont and Confi-Dental Produc. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K101540. 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 GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE?

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Novocol Inc. Dba Septodont and Confi-Dental Produc. The 510(k) number is K101540.

When did GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE receive FDA 510(k) clearance?

GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE received FDA 510(k) clearance on 2010-10-29, under 510(k) number K101540.

Who is the listed applicant for GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE?

The FDA 510(k) record lists Novocol Inc. Dba Septodont and Confi-Dental Produc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE?

The FDA product code for GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE is EBF.

Related Clinical Trials

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Other records listing Novocol Inc. Dba Septodont and Confi-Dental Produc as applicant

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.

K110058BPA-FREE PIT AND FISSURE SEALANT

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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

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

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