FDA 510(k)

Piezosurgery White

K-Number: K171326 · 2018-04-13

Decision Date2018-04-13

Product CodeDZI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Piezosurgery White is a medical device manufactured by Mectron S.P.A.. It received FDA 510(k) clearance on 2018-04-13 under approval number K171326. 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 White?

Piezosurgery White is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by Mectron S.P.A.. The 510(k) number is K171326.

When was Piezosurgery White approved by the FDA?

Piezosurgery White received FDA 510(k) clearance on 2018-04-13, under approval number K171326.

What company makes Piezosurgery White?

Piezosurgery White is manufactured by Mectron S.P.A..

What is the FDA product code for Piezosurgery White?

The FDA product code for Piezosurgery White is DZI.

Other Devices by Mectron S.P.A.

K153743PIEZOSURGERY PLUS K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE K231391Combi Touch K242432MT-Bone K251425turbodent touch

Related Devices (Code: DZI)

K152125Oral Surgery System and AccessoriesBonart Co., Ltd. K172137PIEZOTOME CUBESatelec - Acteon Group K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEMectron S.P.A. K192561TRAUS SUS20Saeshin Precision Co., Ltd. K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad TipBennett Jacoby, Dds, Ms, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.