FDA.reportPublic FDA data

TY MX2 400° calotte Ø20.2x40

Primary DI
J007160080901
Brand
TY MX2 400° calotte Ø20.2x40
Company
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Model
1600809-0
Catalog number
1600809-0
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
2023-12-13
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
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
J007160080901PrimaryHIBCC0

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
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
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
J00716000390011Tur Black Pearl ECO 3H1600039-0011600039-0012021-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301280011WE-57 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301290011HE-43 T SD Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11