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FDA 510(k)

TEMPORARY CROWN & BRIDGE RESIN

K-Number: K060881 · 2006-05-16

ApplicantCosmedent, Inc.
Decision Date2006-05-16
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPORARY CROWN & BRIDGE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2006-05-16 under 510(k) number K060881. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPORARY CROWN & BRIDGE RESIN?

TEMPORARY CROWN & BRIDGE RESIN is a medical device that received FDA 510(k) clearance on 2006-05-16. The listed applicant is Cosmedent, Inc.. The 510(k) number is K060881.

When did TEMPORARY CROWN & BRIDGE RESIN receive FDA 510(k) clearance?

TEMPORARY CROWN & BRIDGE RESIN received FDA 510(k) clearance on 2006-05-16, under 510(k) number K060881.

Who is the listed applicant for TEMPORARY CROWN & BRIDGE RESIN?

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

What is the FDA product code for TEMPORARY CROWN & BRIDGE RESIN?

The FDA product code for TEMPORARY CROWN & BRIDGE RESIN is EBG.

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Related Devices (Code: EBG)

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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