FDA.reportPublic FDA data

NGO motor driver

Primary DI
J00715031850011
Brand
NGO motor driver
Company
Bien-Air Dental SA
Model
1503185-001
Device description
NGO motor driver 1503185-001 Update of the motor control board of the console OPTIMA MX: Added a switch motor on top of the motor board that can control up to 3 motors.
Published
2023-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental
IFPFormalin, Neutral Buffered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1
IFPFormalin, Neutral BufferedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00715031850011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, electricA hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method

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

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