MC MX2 1600677-0

GUDID J007160067701

Electric micromotors are designed to transform electricity into mechanic rotation to drive dental hand-pieces and contra-angles.

Bien-Air Dental SA

Dental surgical power tool motor, electric
Primary Device IDJ007160067701
NIH Device Record Key16cd14a1-4486-492d-9914-4df11f6098f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC MX2
Version Model Number1600677-0
Catalog Number1600677-0
Company DUNS480082080
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
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
HIBCCJ007160067701 [Primary]

FDA Product Code

EFBHandpiece, Air-Powered, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-21
Device Publish Date2023-12-13

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 LED2024-05-02 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.