FDA.reportPublic FDA data

iChiropro Surgery APP

Primary DI
J00714000520521
Brand
iChiropro Surgery APP
Company
Bien-Air Dental SA
Model
1400052
Catalog number
1400052
Device description
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Published
2021-06-23
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
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00714000520521PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

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
480082080
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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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