iOptima APP 1400063

GUDID J00714000630631

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).

Bien-Air Dental SA

Dental treatment application software
Primary Device IDJ00714000630631
NIH Device Record Keyc2c96058-8fc3-4436-a1d8-df7221bc8d1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameiOptima APP
Version Model Number1400063
Catalog Number1400063
Company DUNS480082080
Company NameBien-Air Dental SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00714000630631 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


[J00714000630631]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-01
Device Publish Date2021-06-23

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

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