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FDA 510(k)

SHOFU MZ Primer Plus

K-Number: K172106 · 2017-08-31

ApplicantShofu Dental Corporation
Decision Date2017-08-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SHOFU MZ Primer Plus 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 2017-08-31 under 510(k) number K172106. 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 SHOFU MZ Primer Plus?

SHOFU MZ Primer Plus is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Shofu Dental Corporation. The 510(k) number is K172106.

When did SHOFU MZ Primer Plus receive FDA 510(k) clearance?

SHOFU MZ Primer Plus received FDA 510(k) clearance on 2017-08-31, under 510(k) number K172106.

Who is the listed applicant for SHOFU MZ Primer Plus?

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 MZ Primer Plus?

The FDA product code for SHOFU MZ Primer Plus is KLE.

Other records listing Shofu 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.

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Related Devices (Code: KLE)

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.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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