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FDA 510(k)

TOKUYAMA CUREGRACE

K-Number: K170549 · 2017-07-05

ApplicantTokuyama Dental Corporation
Decision Date2017-07-05
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOKUYAMA CUREGRACE is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2017-07-05 under 510(k) number K170549. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOKUYAMA CUREGRACE?

TOKUYAMA CUREGRACE is a medical device that received FDA 510(k) clearance on 2017-07-05. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K170549.

When did TOKUYAMA CUREGRACE receive FDA 510(k) clearance?

TOKUYAMA CUREGRACE received FDA 510(k) clearance on 2017-07-05, under 510(k) number K170549.

Who is the listed applicant for TOKUYAMA CUREGRACE?

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

What is the FDA product code for TOKUYAMA CUREGRACE?

The FDA product code for TOKUYAMA CUREGRACE is EBI.

Other records listing Tokuyama Dental Corporation 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.

K203760Tokuyama Universal Bond IIK203598Omnichroma Flow BulkK193537Omnichroma FlowK190940Tokuyama Rebase IIIK180613Estelite Universal FlowK173275OMNICHROMA

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Related Devices (Code: EBI)

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.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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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