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FDA 510(k)

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE

K-Number: K171958 · 2018-01-12

ApplicantMectron S.P.A.
Decision Date2018-01-12
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Mectron S.P.A.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171958. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE?

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Mectron S.P.A.. The 510(k) number is K171958.

When did PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE receive FDA 510(k) clearance?

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171958.

Who is the listed applicant for PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE?

The FDA 510(k) record lists Mectron S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE?

The FDA product code for PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE is DZI.

Other records listing Mectron S.P.A. 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.

K251425turbodent touchK242432MT-BoneK231391Combi TouchK171326Piezosurgery WhiteK153743PIEZOSURGERY PLUS

Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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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