FDA.reportPublic FDA data

Foot control S-NW3 (Dongle)

Primary DI
J021304950001
Brand
Foot control S-NW3 (Dongle)
Company
W & H Dentalwerk Bürmoos GmbH
Model
30495000
Device description
Wireless Foot Control
Published
2025-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered
EBWController, Foot, Handpiece And Cord
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
GEYMotor, Surgical Instrument, Ac-Powered
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
EBWController, Foot, Handpiece And CordDental1
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J021304950000Direct MarkingHIBCC0
J021304950001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Regulatory Flags#

DUNS number
300238441
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J021122275011EB-75 Endea 16:1122275012018-08-31
J021122279011EB-79 Endea 2:1122279012018-08-31
J021300010031TG-98 L Megagen300010032022-03-30
J021300040031TG-97 L Megagen300040032022-03-30
J021301040001AM-25 A BC Air Motor301040002023-07-11
J021301120001AM-25 BC Air Motor301120002023-07-11
J021302120011WG-57 LT302120012023-07-11
J021302180001WK-66 LT S302180002019-09-10
J021303100021Assistina Twin MB-302303100022022-11-29
J021303980021MB-301 Assistina ONE303980022022-08-24
J021078122001Tip Set: 1E, 2E, 3E, 4E, 5E, 6E078122002023-08-14
J021058492011Scaler Tip 4U058492012023-07-19
J021058494011Scaler Tip 1R058494012023-07-19
J021063680001Scaler Tip 2E063680002023-07-19
J021063684001Scaler Tip 2R063684002023-07-19
J021063685001Scaler Tip 3Rm063685002023-07-19
J021063686001Scaler Tip 3Rd063686002023-07-19
J021078123001Scaler Tip 4E078123002023-07-19
J021078124001Scaler Tip 5E078124002023-07-19
J021079656001Scaler Tip 5P079656002023-07-19

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