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FDA 510(k)

CHALLENGER DIRECT COMPOSITE

K-Number: K010219 · 2001-02-21

ApplicantInternational Dental Research
Decision Date2001-02-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHALLENGER DIRECT COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is International Dental Research. It received FDA 510(k) clearance on 2001-02-21 under 510(k) number K010219. 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 CHALLENGER DIRECT COMPOSITE?

CHALLENGER DIRECT COMPOSITE is a medical device that received FDA 510(k) clearance on 2001-02-21. The listed applicant is International Dental Research. The 510(k) number is K010219.

When did CHALLENGER DIRECT COMPOSITE receive FDA 510(k) clearance?

CHALLENGER DIRECT COMPOSITE received FDA 510(k) clearance on 2001-02-21, under 510(k) number K010219.

Who is the listed applicant for CHALLENGER DIRECT COMPOSITE?

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

What is the FDA product code for CHALLENGER DIRECT COMPOSITE?

The FDA product code for CHALLENGER DIRECT COMPOSITE is EBF.

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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.

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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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