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FDA 510(k)

VISCOSTAT CLEAR

K-Number: K123215 · 2013-02-05

Decision Date2013-02-05
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

VISCOSTAT CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2013-02-05 under 510(k) number K123215. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISCOSTAT CLEAR?

VISCOSTAT CLEAR is a medical device that received FDA 510(k) clearance on 2013-02-05. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K123215.

When did VISCOSTAT CLEAR receive FDA 510(k) clearance?

VISCOSTAT CLEAR received FDA 510(k) clearance on 2013-02-05, under 510(k) number K123215.

Who is the listed applicant for VISCOSTAT CLEAR?

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

What is the FDA product code for VISCOSTAT CLEAR?

The FDA product code for VISCOSTAT CLEAR is MVL.

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 Ultradent Products, 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.

View all 102 devices →

Related Devices (Code: MVL)

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

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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