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FDA 510(k)

VATEA ENDONTIC IRRIGATION SYSTEM

K-Number: K100606 · 2010-05-28

ApplicantRedent Nova, Ltd.
Decision Date2010-05-28
Product CodeNYL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VATEA ENDONTIC IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Redent Nova, Ltd.. It received FDA 510(k) clearance on 2010-05-28 under 510(k) number K100606. The device is classified under product code NYL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VATEA ENDONTIC IRRIGATION SYSTEM?

VATEA ENDONTIC IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-28. The listed applicant is Redent Nova, Ltd.. The 510(k) number is K100606.

When did VATEA ENDONTIC IRRIGATION SYSTEM receive FDA 510(k) clearance?

VATEA ENDONTIC IRRIGATION SYSTEM received FDA 510(k) clearance on 2010-05-28, under 510(k) number K100606.

Who is the listed applicant for VATEA ENDONTIC IRRIGATION SYSTEM?

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

What is the FDA product code for VATEA ENDONTIC IRRIGATION SYSTEM?

The FDA product code for VATEA ENDONTIC IRRIGATION SYSTEM is NYL.

Related Clinical Trials

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Other records listing Redent Nova, Ltd. 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.

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Related Devices (Code: NYL)

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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