TUR BORA LK BLACKLINE 1600731-001

GUDID J00716007310011

Turbines are intended to generate rotating mechanical energy from compressed air

Bien-Air Dental SA

Dental power tool system handpiece, pneumatic
Primary Device IDJ00716007310011
NIH Device Record Keyc7275b51-6dc4-4bf6-a3ec-cefc9ad7806d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTUR BORA LK BLACKLINE
Version Model Number1600731-001
Catalog Number1600731-001
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00716007310011 [Primary]

FDA Product Code

EFBHandpiece, air-powered, dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


[J00716007310011]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

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J00716012470011 - LIGHT MOTOR2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
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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.
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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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