Mectron North America

FDA Device Registration & Listing · Hilliard, OH, US · Registration 3005282635

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005282635
FEI Number
3005282635
Entity Name
Mectron North America
City/State/Country
Hilliard, OH, US
Establishment Address
4115 Leap Rd, Hilliard, OH 43026, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Piezosurgery, Inc DBA Mectron North America (Owner Number: 9075679)
Owner / Operator Contact Address
4115 Leap Road, Hilliard, OH 43026, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K153743
PMA Number
N/A

All Registered Proprietary Names

MULTIPIEZO, MULTIPIEZO PRO COMPACT PIEZO LED Piezosurgery Touch SteriZign Piezosurgery // MT-Bone Piezosurgery Flex WISER Piezosurgery GP Device Piezosurgery Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2016-06-29
DZI Drill, Bone, Powered Dental Class 2 872.4120 2013-03-28
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2013-03-28
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2021-12-16
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2013-04-29
DZI Drill, Bone, Powered Dental Class 2 872.4120 2024-09-17
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2024-09-17
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-02-09
DZI Drill, Bone, Powered Dental Class 2 872.4120 2017-02-09
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-02-09
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2017-02-09
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2017-02-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-12-16
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2018-01-22
DZI Drill, Bone, Powered Dental Class 2 872.4120 2018-01-22
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2017-02-09
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2017-02-09
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-02-09
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-02-09
DZI Drill, Bone, Powered Dental Class 2 872.4120 2017-02-09

Official Correspondent

Richelle Braun

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Piezosurgery, Inc DBA Mectron North America
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
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005282635. Last updated year: 2026. Please use registration number 3005282635 when referencing this establishment in official correspondence.
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