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FDA 510(k)

FUSION RESIN CEMENT AND CORE KIT

K-Number: K070702 · 2007-05-10

ApplicantDenali Corporation
Decision Date2007-05-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUSION RESIN CEMENT AND CORE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Denali Corporation. It received FDA 510(k) clearance on 2007-05-10 under 510(k) number K070702. 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 FUSION RESIN CEMENT AND CORE KIT?

FUSION RESIN CEMENT AND CORE KIT is a medical device that received FDA 510(k) clearance on 2007-05-10. The listed applicant is Denali Corporation. The 510(k) number is K070702.

When did FUSION RESIN CEMENT AND CORE KIT receive FDA 510(k) clearance?

FUSION RESIN CEMENT AND CORE KIT received FDA 510(k) clearance on 2007-05-10, under 510(k) number K070702.

Who is the listed applicant for FUSION RESIN CEMENT AND CORE KIT?

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

What is the FDA product code for FUSION RESIN CEMENT AND CORE KIT?

The FDA product code for FUSION RESIN CEMENT AND CORE KIT is EBF.

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Other records listing Denali Corporation 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.

K153191Calcium BridgeK151945Triumph Resin DamK073101AURAVENEER CEMENTK071158AURALAY PIT & FISSURE SEALANTK070693AURAVUE PIT & FISSURE SEALANT

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

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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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