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FDA 510(k)

PANAVIA Veneer LC

K-Number: K210504 · 2021-06-11

ApplicantKuraray Noritake Dental, Inc.
Decision Date2021-06-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANAVIA Veneer LC is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K210504. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANAVIA Veneer LC?

PANAVIA Veneer LC is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K210504.

When did PANAVIA Veneer LC receive FDA 510(k) clearance?

PANAVIA Veneer LC received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210504.

Who is the listed applicant for PANAVIA Veneer LC?

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

What is the FDA product code for PANAVIA Veneer LC?

The FDA product code for PANAVIA Veneer LC is EMA.

Other records listing Kuraray Noritake Dental, Inc. as applicant

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Related Devices (Code: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco 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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