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FDA 510(k)

SHOFU RESIN GLAZE

K-Number: K163568 · 2017-08-16

ApplicantShofu Dental Corporation
Decision Date2017-08-16
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SHOFU RESIN GLAZE is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2017-08-16 under 510(k) number K163568. 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 SHOFU RESIN GLAZE?

SHOFU RESIN GLAZE is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Shofu Dental Corporation. The 510(k) number is K163568.

When did SHOFU RESIN GLAZE receive FDA 510(k) clearance?

SHOFU RESIN GLAZE received FDA 510(k) clearance on 2017-08-16, under 510(k) number K163568.

Who is the listed applicant for SHOFU RESIN GLAZE?

The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHOFU RESIN GLAZE?

The FDA product code for SHOFU RESIN GLAZE is EBD.

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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 & COK162408Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH

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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