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FDA 510(k)

AXCEL

K-Number: K051931 · 2006-02-17

ApplicantTri Dental Innovators
Decision Date2006-02-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AXCEL is the device name listed in this FDA 510(k) record. The listed applicant is Tri Dental Innovators. It received FDA 510(k) clearance on 2006-02-17 under 510(k) number K051931. 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 AXCEL?

AXCEL is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Tri Dental Innovators. The 510(k) number is K051931.

When did AXCEL receive FDA 510(k) clearance?

AXCEL received FDA 510(k) clearance on 2006-02-17, under 510(k) number K051931.

Who is the listed applicant for AXCEL?

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

What is the FDA product code for AXCEL?

The FDA product code for AXCEL is EBF.

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 Tri Dental Innovators 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.

K063714AXCEL FLOW

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

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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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