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FDA 510(k)

DC-TELL

K-Number: K001799 · 2000-08-10

ApplicantAustenal, Inc.
Decision Date2000-08-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DC-TELL is the device name listed in this FDA 510(k) record. The listed applicant is Austenal, Inc.. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K001799. 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 DC-TELL?

DC-TELL is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Austenal, Inc.. The 510(k) number is K001799.

When did DC-TELL receive FDA 510(k) clearance?

DC-TELL received FDA 510(k) clearance on 2000-08-10, under 510(k) number K001799.

Who is the listed applicant for DC-TELL?

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

What is the FDA product code for DC-TELL?

The FDA product code for DC-TELL is EBF.

Other records listing Austenal, 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.

K011674DC - CRISTALK001815DC ZIRKONK001798DC TITANK970522MYERSON'S ECONOMY DENTURE BASE MATERIALK970205VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOYK955509MIDAS GOLD ELECTROFORMING SYSTEM

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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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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