FDA.reportPublic FDA data

HOSE MX2 400 GREY_102646

Primary DI
J0071602490011
Brand
HOSE MX2 400 GREY_102646
Company
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Model
1601249-001
Device description
Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J0071602490011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental power tool hoseA single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed gas from a source to a dental drilling system handpiece to provide power to the turbine. The device is of an adequate length to provide manoeuvrability of the handpiece. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

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