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FDA 510(k)

INVIVO DENTAL

K-Number: K123519 · 2013-02-01

Decision Date2013-02-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INVIVO DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Anatomage, Inc.. It received FDA 510(k) clearance on 2013-02-01 under 510(k) number K123519. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVIVO DENTAL?

INVIVO DENTAL is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is Anatomage, Inc.. The 510(k) number is K123519.

When did INVIVO DENTAL receive FDA 510(k) clearance?

INVIVO DENTAL received FDA 510(k) clearance on 2013-02-01, under 510(k) number K123519.

Who is the listed applicant for INVIVO DENTAL?

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

What is the FDA product code for INVIVO DENTAL?

The FDA product code for INVIVO DENTAL is LLZ.

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 Anatomage, 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: LLZ)

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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