Skip to the page
Get started – free

Data / Medical devices / Switzerland / Maillefer Instruments Holding Sarl

Maillefer Instruments Holding Sarl: FDA-registered device maker in BALLAIGUES Vaud, Switzerland, 1 510(k) clearance

Maillefer Instruments Holding Sarl is registered with the FDA (registration 8031010) in BALLAIGUES Vaud, Switzerland. It lists 33 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2013. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Maillefer Instruments Holding Sarl
FDA registration number
8031010
FEI number
1000185904
Address
CH. Du Verger 3, BALLAIGUES Vaud, Switzerland, CH-1338
Owner or operator
DENTSPLY SIRONA INC (2511302)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 15, 1977
Registered through
2026
Brand names listed
Bracket Height Gauge, Caulk Post & Core Kit, Dental Tools, Drill single patient use, Drills, EMERGENCE PROFILE, GATES, LARGO and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Contract manufactureraccessdata.fda.gov
Bit, DrillHTW1Contract manufactureraccessdata.fda.gov
Broach, EndodonticEKW1Exporter to the USaccessdata.fda.gov
Bur, DentalEJL1Contract manufacturer, Manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Contract manufactureraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Contract manufacturer, Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Contract manufactureraccessdata.fda.gov
Driver, Wire, And Bone Drill, ManualDZJ2Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Contract manufactureraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Specification developeraccessdata.fda.gov
Handle, Instrument, DentalEJB1Contract manufacturer, Manufactureraccessdata.fda.gov
Hearing Aid, Bone ConductionLXB2Contract manufactureraccessdata.fda.gov
Hearing Aid, Bone Conduction, ImplantedMAH2Contract manufactureraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Manufactureraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Manufactureraccessdata.fda.gov
Instrument, Hand, Calculus RemovalELA1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Locator, Root ApexLQYUExporter to the USaccessdata.fda.gov
Mesh, Surgical, MetalEZX2Contract manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Plate, BoneJEY2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Manufactureraccessdata.fda.gov
Point, Paper, EndodonticEKN1Specification developeraccessdata.fda.gov
Post, Root CanalELR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Prosthesis, Nose, InternalFZE2Contract manufactureraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Contract manufacturer, Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Exporter to the US, Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 10, 2013K121206DETECTLQYSubstantially EquivalentForum Engineering Technologies, Ltd.accessdata.fda.gov

Compare with other makers

Updated January 10, 2013. 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.