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FDA 510(k)

CFS FLEXIBLE

K-Number: K081537 · 2009-01-22

ApplicantComfort and Flexible Systems
Decision Date2009-01-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CFS FLEXIBLE is the device name listed in this FDA 510(k) record. The listed applicant is Comfort and Flexible Systems. It received FDA 510(k) clearance on 2009-01-22 under 510(k) number K081537. 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 CFS FLEXIBLE?

CFS FLEXIBLE is a medical device that received FDA 510(k) clearance on 2009-01-22. The listed applicant is Comfort and Flexible Systems. The 510(k) number is K081537.

When did CFS FLEXIBLE receive FDA 510(k) clearance?

CFS FLEXIBLE received FDA 510(k) clearance on 2009-01-22, under 510(k) number K081537.

Who is the listed applicant for CFS FLEXIBLE?

The FDA 510(k) record lists Comfort and Flexible Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CFS FLEXIBLE?

The FDA product code for CFS FLEXIBLE is EBI.

Related Clinical Trials

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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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