Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003933619

FEI Number

3003933619

Entity Name

MECTRON S.P.A.

City/State/Country

CARASCO Genova, IT

Establishment Address

15, VIA LORETO, CARASCO Genova 16042, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MECTRON S.P.A. (Owner Number: 9078459)

Owner / Operator Contact Address

15, VIA LORETO, --, CARASCO, IT-GE 16042, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140965

PMA Number

N/A

All Registered Proprietary Names

PIEZOSURGERY TOUCH combi touch PIEZOSURGERY GP PIEZOSURGERY FLEX SINUS PHYSIOLIFT II BONE EXPANDERS SINUS PHYSIOLIFT MULTIPIEZO PRO - MULTIPIEZO K10 K6 P16R P15 P16L SLIM SCALER HANDPIECE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2012-12-14
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2012-12-14
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2018-01-22
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2018-01-22
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2015-10-09
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2015-10-09
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	Class 2	888.4580	2013-12-12
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-12-12
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-12-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-12-12
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2013-12-12
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2009-11-23
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2014-09-01

Official Correspondent

chiara acunzo

US Agent Details

Richelle Braun Business: Piezosurgery Inc. DBA Mectron North America Email: r.braun@mectron.us Phone: (817) 6021363

Related Public Records

Same Entity

MECTRON S.P.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003933619. Last updated year: 2026. Please use registration number 3003933619 when referencing this establishment in official correspondence.