FDA.reportPublic FDA data

CABLE MX-i LED 3RD GEN

Primary DI
J00716010090011
Brand
CABLE MX-i LED 3RD GEN
Company
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Model
1601009-001
Catalog number
1601009-001
Device description
Accessory connects micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
Published
2021-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBWController, foot, handpiece and cord

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00716010090011PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
338234588
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J00716009110011CA 8:11600911-0012026-05-22
J00715021220011BOARD DMX3 M Bornier1502122-0012026-02-24
J00715021230011BOARD DMX3 M BtoB1502123-0012026-02-24
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
J00716012480011HOSE LIGHT MOTOR1601248-0012024-04-25
J007160080901TY MX2 400° calotte Ø20.2x40 1600809-01600809-02023-12-13
J00710433450011HOSE 6 HOLE L GREY MIDWEST1043345-0011043345-0012021-06-17
J00710433480011HOSE 5 HOLE L GREY MIDWEST1043348-0011043348-0012021-06-17
J00710438070011HOSE 4VLM11 SURF6 ADEC1043807-0011043807-0012021-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975069252SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069276Sterling Surgical Motor Main ConsoleBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069283SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069290SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069306SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19