SET OPTIMA MX2 EDUCATIONAL 6 1700817-0

GUDID J007170081701

Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit.

Bien-Air Dental SA

Surgical power tool system control unit, line-powered
Primary Device IDJ007170081701
NIH Device Record Keydb011faf-b51b-4544-a0ea-a15357e6a7c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSET OPTIMA MX2 EDUCATIONAL 6
Version Model Number1700817-0
Catalog Number1700817-0
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
HIBCCJ007170081701 [Primary]

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

Moist Heat or Steam Sterilization


[J007170081701]

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

On-Brand Devices [SET OPTIMA MX2 EDUCATIONAL 6]

J007170081701Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connecte
J00717008170011Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connecte

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