FDA.reportPublic FDA data

SET STUDENTS BAUSA 13

Primary DI
J007170084201
Brand
SET STUDENTS BAUSA 13
Company
Bien-Air Dental SA
Model
1700842-0
Catalog number
1700842-0
Device description
SET of different CA & HP supplied for students.
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
J007170084201PrimaryHIBCC0

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

Contacts#

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

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
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
J00717007960011SET STUDENTS BAUSA 71700796-0011700796-0012020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D950133802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
J0071602490011HOSE MX2 400 GREY_102646BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-08-27
07613353240011AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353239992AIR-FLOW Handpiece 120°E.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353240134PERIO-FLOW HandpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353312558AIR-FLOW® PLUS handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14