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FDA 510(k)

DURAFLEX

K-Number: K063626 · 2007-02-08

ApplicantCosmetic Dental Materials, Inc.
Decision Date2007-02-08
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURAFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Cosmetic Dental Materials, Inc.. It received FDA 510(k) clearance on 2007-02-08 under 510(k) number K063626. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAFLEX?

DURAFLEX is a medical device that received FDA 510(k) clearance on 2007-02-08. The listed applicant is Cosmetic Dental Materials, Inc.. The 510(k) number is K063626.

When did DURAFLEX receive FDA 510(k) clearance?

DURAFLEX received FDA 510(k) clearance on 2007-02-08, under 510(k) number K063626.

Who is the listed applicant for DURAFLEX?

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

What is the FDA product code for DURAFLEX?

The FDA product code for DURAFLEX is EBI.

Related Clinical Trials

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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Other records listing Cosmetic Dental Materials, Inc. 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.

K052040QUICKSMILE

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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