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FDA 510(k)

INTRAORAL BELSENSOR GOLD

K-Number: K102456 · 2011-12-15

Decision Date2011-12-15
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRAORAL BELSENSOR GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont USA, Inc.. It received FDA 510(k) clearance on 2011-12-15 under 510(k) number K102456. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAORAL BELSENSOR GOLD?

INTRAORAL BELSENSOR GOLD is a medical device that received FDA 510(k) clearance on 2011-12-15. The listed applicant is Takara Belmont USA, Inc.. The 510(k) number is K102456.

When did INTRAORAL BELSENSOR GOLD receive FDA 510(k) clearance?

INTRAORAL BELSENSOR GOLD received FDA 510(k) clearance on 2011-12-15, under 510(k) number K102456.

Who is the listed applicant for INTRAORAL BELSENSOR GOLD?

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

What is the FDA product code for INTRAORAL BELSENSOR GOLD?

The FDA product code for INTRAORAL BELSENSOR GOLD is MUH.

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.

Other records listing Takara Belmont USA, 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.

Related Devices (Code: MUH)

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.

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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