I-SURGER LED

GUDID J00716012450011

The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedicated bur fixed to an adequate contra-angle or straight handpiece for different clinical applications. The micromotor connected to a cable or a hose depending on the type (the hose integrates water and air connection) is driven using an electronic control either integrated in a dental console or a dental unit.

Bien-Air Dental SA

Dental surgical power tool motor, electric
Primary Device IDJ00716012450011
NIH Device Record Keye57aed55-a7da-4bf9-915c-efb8722b6d8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-SURGER LED
Version Model Number1601245-001
Company DUNS480407528
Company NameBien-Air Dental SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com
Phone+1 949-477-6050
Emailba-usa@bienair.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00716012450011 [Primary]

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


[J00716012450011]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-02
Device Publish Date2024-04-24

Devices Manufactured by Bien-Air Dental SA

J00716012420011 - XPU MMOTOR LIGHT2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
J00716012450011 - I-SURGER LED2024-05-02The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedicated bur fixed to an adequate contra-angle or straight handpiece for different clinical applications. The micromotor connected to a cable or a hose depending on the type (the hose integrates water and air connection) is driven using an electronic control either integrated in a dental console or a dental unit.
J00716012450011 - I-SURGER LED2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
J00716012470011 - LIGHT MOTOR2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
J00717008000011 - SET STUDENTS BAUSA 82024-01-31 SET of different CA & HP supplied for students.
J00717008170011 - SET OPTIMA MX2 EDUCATIONAL 62024-01-31 Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit.
J00717008420011 - SET STUDENTS BAUSA 132024-01-31 SET of different CA & HP supplied for students.
J00717008570011 - SET STUDENTS BAUSA 142024-01-31 SET of different CA & HP supplied for students.
J007160005201 - PM HP 1:1 sp. ext.2023-12-21 CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain

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