FDA.reportPublic FDA data

MC3 LK + 4VLM

Primary DI
J00717003360011
Brand
MC3 LK + 4VLM
Company
Bien-Air Dental SA
Model
1700336-001
Catalog number
1700336-001
Device description
Set of micromotor and Accessory connects micro-motors to the console
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
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
J00717003360011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental handpiece couplerA short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
480082080
Device count
1
Serial number
true
Manufacturing date on label
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
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
J00717007960011SET STUDENTS BAUSA 71700796-0011700796-0012020-05-11

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