FDA.reportPublic FDA data

CABLE MX-i LED

Primary DI
J00716010690011
Brand
CABLE MX-i LED
Company
Bien-Air Dental SA
Model
1601069-001
Catalog number
1601069-001
Device description
Cables are essential accessories meant to connect motors to the Bien-Air pro-prietary consoles or to unit/chairs.
Published
2023-02-01
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
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
J00716010690011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
480082080
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J00717008000011SET STUDENTS BAUSA 81700800-0011700800-0012024-01-23
J00717008420011SET STUDENTS BAUSA 131700842-0011700842-0012024-01-23
J00717008570011SET STUDENTS BAUSA 141700857-0011700857-0012024-01-23
J007170079601SET STUDENTS BAUSA 71700796-01700796-02023-12-13
J007170080001SET STUDENTS BAUSA 81700800-01700800-02023-12-13
J007170084201SET STUDENTS BAUSA 131700842-01700842-02023-12-13
J007170085701SET STUDENTS BAUSA 141700857-01700857-02023-12-13
J00717000430011Set B-4VR400 Grey + Socket B1700043-0011700043-0012021-06-17
J00717000460011MC3 LK + 4VR4001700046-0011700046-0012021-06-17
J00717000580011Set Aquilon830 IR NC + Unifix 3H1700058-0011700058-0012021-06-17
J00717002110011Set Aquilon830 IR C + Unifix 4H1700211-0011700211-0012021-06-17
J00717002120011Set Aquilon830 SR + Unifix 3H1700212-0011700212-0012021-06-17
J00717002130011Set Aquilon830 SR + Unifix 4H1700213-0011700213-0012021-06-17
J00717003360011MC3 LK + 4VLM1700336-0011700336-0012021-06-17
J00717003370011Set MC3 IR + 4VLM-11 Grey1700337-0011700337-0012021-06-17
J00717004450011Set MC3 LED + 4VR400 Grey1700445-0011700445-0012021-06-17
J00717004460011Set MC3 LED + 4VLM-111700446-0011700446-0012021-06-17
J00717007930011SET STUDENTS BAUSA 41700793-0011700793-0012020-05-11
J00717007941001SET STUDENTS BAUSA 51700794-0011700794-0012020-05-11
J00717007950011SET STUDENTS BAUSA 61700795-0011700795-0012020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHEBW2026-02-17
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEBW2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEBW2026-02-13
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.EBW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.EBW2026-01-09
08404535021684ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
08404535021714ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
04589551393381Straumann SGL80MNAKANISHI INC.EBW2026-01-03
04589551393374Straumann Surgical Motor Pro 2NAKANISHI INC.EBW2026-01-03
04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHEBW2025-12-18