PM 1:1 TWIST DRILL 1601190-001

GUDID J00716011900011

Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor. Product intended for use in oral and maxillofacial surgery.

Bien-Air Dental SA

Dental laboratory drilling system handpiece
Primary Device IDJ00716011900011
NIH Device Record Key88f55f38-337a-44e9-9c24-afa1d58e69cf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePM 1:1 TWIST DRILL
Version Model Number1601190-001
Catalog Number1601190-001
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 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ00716011900011 [Primary]

FDA Product Code

EFBHandpiece, Air-Powered, Dental
GFABlade, Saw, General & Plastic Surgery, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-20
Device Publish Date2022-07-12

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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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