| Primary Device ID | J007160067701 |
| NIH Device Record Key | 16cd14a1-4486-492d-9914-4df11f6098f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MC MX2 |
| Version Model Number | 1600677-0 |
| Catalog Number | 1600677-0 |
| Company DUNS | 480082080 |
| 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 | |
| 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 | J007160067701 [Primary] |
| EFB | Handpiece, Air-Powered, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
[J007160067701]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-21 |
| Device Publish Date | 2023-12-13 |
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| 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 |