FDA.reportPublic FDA data

BOARD DMX3 M BtoB

Primary DI
J00715021230011
Brand
BOARD DMX3 M BtoB
Company
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Model
1502123-001
Device description
Boards are essential accessories meant to drive electrical micro-motors
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00715021230011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Contacts#

Phone, Email table
PhoneEmail
+1 949-477-6050ba-usa@bienair.com

Regulatory Flags#

DUNS number
338234588
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J0071600052001USA1PM 1:1 EXT SPRAY1600052-001USA2025-10-10
J0071600436001USA1PM 1:21600436-001USA2025-10-13
J0071600692001USA1CA 20:1 L MICRO-SERIES1600692-001USA2025-10-10
J0071601136001USA1CA NOVA 1:1L MS1601136-001USA2025-10-10
J0071601138001USA1CA NOVA 1:5L MS1601138-001USA2025-10-10
J0071602490011HOSE MX2 400 GREY_1026461601249-0012026-08-27
J00716009110011CA 8:11600911-0012026-05-22
J00715021220011BOARD DMX3 M Bornier1502122-0012026-02-24
J0071600677001USA1MOT MX21600677-001USA2025-10-13
J0071600755001USA1MOT MX-i LED1600755-001USA2025-10-13
J00716000710011Mot MC3 IR1600071-0011600071-0012021-06-17
J00716000730011Mot MC2 IR1600073-0011600073-0012021-06-17
J00716000750011Mot MC2 GT AV1600075-0011600075-0012021-06-17
J00716000770011Mot MC3 LK1600077-0011600077-0012021-06-17
J00716006330011Mot MC2 40 GT IR1600633-0011600633-0012021-06-17
J00716006800011MOT MC31600680-0011600680-0012021-06-17
J0071600386001USA1CA 1:5 L1600386-001USA2025-12-05
J00716012430011XPU MMOTOR CABLE1601243-0012024-04-25
J00716012440011XPU MMOTOR NO LIGHT1601244-0012024-04-24
J00716012460011CABLE I-SURGE LED1601246-0012024-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975220031162Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975220031179Dental UnitLakong Medical Devices Co., Ltd.EIA2026-10-20
06975659690060YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690077YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690107YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-09
06975659690114YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-07
00841709109805MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109812MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109843MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109850MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109874MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709109881MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110030MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110054MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709110061MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111846MidmarkMIDMARK CORPORATIONEIA2026-09-28
00841709111853MidmarkMIDMARK CORPORATIONEIA2026-09-28
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
07898971838004OlsenOlsen Indústria e Comércio S/AEIA2026-04-22
J00715021220011BOARD DMX3 M BornierBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
00850043433521E300 Delivery SystemEngle Dental Systems, LLCEIA2026-02-09
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-09-04
00850043433514E300 Dr./Asst Rear DeliveryEngle Dental Systems, LLCEIA2025-08-26
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EIA2025-04-24
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyEngle Dental Systems, LLCEIA2024-11-06
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08