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FDA 510(k)

Nano Varnish, Plaquit, Lightpaint on Surface

K-Number: K162408 · 2018-04-05

ApplicantDreve Dentamid GmbH
Decision Date2018-04-05
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nano Varnish, Plaquit, Lightpaint on Surface is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K162408. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nano Varnish, Plaquit, Lightpaint on Surface?

Nano Varnish, Plaquit, Lightpaint on Surface is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K162408.

When did Nano Varnish, Plaquit, Lightpaint on Surface receive FDA 510(k) clearance?

Nano Varnish, Plaquit, Lightpaint on Surface received FDA 510(k) clearance on 2018-04-05, under 510(k) number K162408.

Who is the listed applicant for Nano Varnish, Plaquit, Lightpaint on Surface?

The FDA 510(k) record lists Dreve Dentamid GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface?

The FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface is EBD.

Other records listing Dreve Dentamid GmbH 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: EBD)

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.

K254091GLOSSY COAT (15ML)YAMAHACHI DENTAL MFG., Co.K250804ID LIGHT CURE SYSTEMId Korea Co., Ltd.K240735visio.lign color, visio.lign shieldBredent GmbH & Co. KGK223365RODIN Palette Naturalizing KitBelport Company, Inc., Gingi-PakK211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & COK163568SHOFU RESIN GLAZEShofu Dental Corporation

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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