Data / Medical devices / United States / Mectron North America
Mectron North America: FDA-registered device maker in Hilliard, OH, United States, 13 510(k) clearances
Mectron North America is registered with the FDA (registration 3005282635) in Hilliard, OH, United States. It lists 8 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005282635
- Address
- 4115 Leap Rd, Hilliard, OH, United States, 43026
- Owner or operator
- Piezosurgery, Inc DBA Mectron North America (9075679)
- Roles
- Complaint file establishment
- First device listed
- March 28, 2013
- Registered through
- 2026
- Brand names listed
- COMPACT PIEZO LED, MT-Bone, MULTIPIEZO, MULTIPIEZO PRO, Piezosurgery //, Piezosurgery 3, Piezosurgery Flex, Piezosurgery GP Device, Piezosurgery Medical and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drill, Bone, Powered | DZI | 2 | Complaint file establishment | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Complaint file establishment | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | 2 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2024 | K242432 | MT-Bone | DZI | Substantially Equivalent | Mectron S.P.A. | accessdata.fda.gov |
| February 7, 2018 | K171520 | SteriZign Signatur Device Protection System | KCT | Substantially Equivalent | Sterizign Precision Technologies, LLC | accessdata.fda.gov |
| May 25, 2016 | K153743 | PIEZOSURGERY PLUS | JDX | Substantially Equivalent | Mectron S.P.A. | accessdata.fda.gov |
| September 4, 2015 | K151248 | PIEZOSURGERY WHITE | DZI | Substantially Equivalent | Mectron S.P.A. | accessdata.fda.gov |
| August 5, 2015 | K151023 | COMPACT PIEZO LED | ELC | Substantially Equivalent | Mectron S.P.A. | accessdata.fda.gov |
| August 20, 2014 | K140965 | MULTIPIEZO PRO, MULTIPIEZO | ELC | Substantially Equivalent | Mectron S.P.A. | accessdata.fda.gov |
| November 29, 2013 | K132848 | PIEZOSURGERY FLEX | JDX | Substantially Equivalent | Mectron S.P.A. | accessdata.fda.gov |
| December 6, 2012 | K122322 | PIEZOSURGERY TOUCH | DZI | Substantially Equivalent | Mectron S.P.A. | accessdata.fda.gov |
| December 29, 2009 | K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | DZI | Substantially Equivalent | Piezosurgery S.R.L. | accessdata.fda.gov |
| September 8, 2009 | K091562 | DOCTOR SMILE A-810 AND B-980 LASERS | GEX | Substantially Equivalent | Lambda Scientific Spa | accessdata.fda.gov |
| April 8, 2009 | K083284 | PIEZOSURGERY MEDICAL | JDX | Substantially Equivalent | Piezosurgery S.R.L. | accessdata.fda.gov |
| November 16, 2005 | K052518 | PIEZOSURGERY | ELC | Substantially Equivalent | Piezosurgery S.R.L. | accessdata.fda.gov |
| June 8, 2005 | K043408 | PIEZOSURGERY DEVICE | DZI | Substantially Equivalent | Piezosurgery S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Bone, Powered
- All makers of Drills, Burrs, Trephines & Accessories (Simple, Powered)
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Instrument, Surgical, Sonic And Accessory/Attachment
- All makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- All makers of Scaler, Ultrasonic
Updated August 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.