| Primary Device ID | J00716012450011 |
| NIH Device Record Key | e57aed55-a7da-4bf9-915c-efb8722b6d8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | I-SURGER LED |
| Version Model Number | 1601245-001 |
| Company DUNS | 480407528 |
| Company Name | Bien-Air Dental SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J00716012450011 [Primary] |
| EFB | Handpiece, Air-Powered, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-02 |
| Device Publish Date | 2024-04-24 |
| J00716012420011 - XPU MMOTOR LIGHT | 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic |
| J00716012450011 - I-SURGER LED | 2024-05-02The 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 LED | 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic |
| J00716012470011 - LIGHT MOTOR | 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic |
| J00717008000011 - SET STUDENTS BAUSA 8 | 2024-01-31 SET of different CA & HP supplied for students. |
| J00717008170011 - SET OPTIMA MX2 EDUCATIONAL 6 | 2024-01-31 Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit. |
| J00717008420011 - SET STUDENTS BAUSA 13 | 2024-01-31 SET of different CA & HP supplied for students. |
| J00717008570011 - SET STUDENTS BAUSA 14 | 2024-01-31 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 |