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FDA 510(k)

DENTOCORE / DENTOCORE BODY

K-Number: K121769 · 2013-03-05

ApplicantItena Clinical
Decision Date2013-03-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTOCORE / DENTOCORE BODY is the device name listed in this FDA 510(k) record. The listed applicant is Itena Clinical. It received FDA 510(k) clearance on 2013-03-05 under 510(k) number K121769. 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 DENTOCORE / DENTOCORE BODY?

DENTOCORE / DENTOCORE BODY is a medical device that received FDA 510(k) clearance on 2013-03-05. The listed applicant is Itena Clinical. The 510(k) number is K121769.

When did DENTOCORE / DENTOCORE BODY receive FDA 510(k) clearance?

DENTOCORE / DENTOCORE BODY received FDA 510(k) clearance on 2013-03-05, under 510(k) number K121769.

Who is the listed applicant for DENTOCORE / DENTOCORE BODY?

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

What is the FDA product code for DENTOCORE / DENTOCORE BODY?

The FDA product code for DENTOCORE / DENTOCORE BODY is EBF.

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Other records listing Itena Clinical as applicant

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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

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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