Footctrl 1600631-001

GUDID J00716006310011

Used to control the console used in dentistry for implantology, dental surgery and endodontic work.

Bien-Air Dental SA

Surgical power tool system control unit, line-powered
Primary Device IDJ00716006310011
NIH Device Record Key9766041f-60ad-4e5d-b5c1-60195928704e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFootctrl
Version Model Number1600631-001
Catalog Number1600631-001
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
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
HIBCCJ00716006310011 [Primary]

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-25
Device Publish Date2021-06-17

Devices Manufactured by Bien-Air Dental SA

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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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