| 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 |
| J00716012350011 - CA PRIMA 1:1 | 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele |
| J00716012360011 - CA PRIMA 1:1 L | 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele |
| J00716012370011 - CA PRIMA 1:1 L MS | 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele |
| J00716012670011 - CA PRIMA 1:121 | 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele |
| J00716014080011 - PM CA 20:1 L RO 104936 | 2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele |
| J00716014090011 - PM PM 1:1 RO sp. ext. 104936 | 2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele |
| 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 | 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic |