FDA.reportPublic FDA data

MC-1.0 and AD-1.0 Analog Motorcontroller

Primary DI
J021302780001
Brand
MC-1.0 and AD-1.0 Analog Motorcontroller
Company
W & H Dentalwerk Bürmoos GmbH
Model
30278000
Device description
Motor Controller for Built-in solutions
Published
2023-07-11
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
EBWController, Foot, Handpiece And Cord
EIAUnit, Operative Dental
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1
EIAUnit, Operative DentalDental1
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J021302780000Direct MarkingHIBCC0
J021302780001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

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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Primary DI, Brand, Company table
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08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
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08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
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08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
07630392912617BioSonicDent4You AGELC2026-04-06
07630392912624BioSonicDent4You AGELC2026-04-06
07630392912631BioSonicDent4You AGELC2026-04-06
07630392912648BioSonicDent4You AGELC2026-04-06
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
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J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
10194665008444A-decA-DEC, INC.EBW2026-02-19
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J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
07613353335113PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-21
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07613353257224AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
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08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11