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FDA 510(k)

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel

K-Number: K172977 · 2018-01-16

ApplicantNanova Biomaterials, Inc.
Decision Date2018-01-16
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is a medical device manufactured by Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2018-01-16 under approval number K172977. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is a medical device that received FDA 510(k) clearance on 2018-01-16. It is manufactured by Nanova Biomaterials, Inc.. The 510(k) number is K172977.

When was Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel approved by the FDA?

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel received FDA 510(k) clearance on 2018-01-16, under approval number K172977.

What company makes Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is manufactured by Nanova Biomaterials, Inc..

What is the FDA product code for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

The FDA product code for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is KLE.

Related Clinical Trials

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Other Devices by Nanova Biomaterials, Inc.

K161174Nanova Interference Screw K151943Vas-Q-Clip K171330Nanova Sealant K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor

Related Devices (Code: KLE)

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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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