SET BIOPOWER 1700784-001

GUDID J00717007840011

Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories

Bien-Air Dental SA

Surgical power tool system control unit, line-powered
Primary Device IDJ00717007840011
NIH Device Record Key3e6c53b8-c4bd-4d82-b945-3deb2d075876
Commercial Distribution StatusIn Commercial Distribution
Brand NameSET BIOPOWER
Version Model Number1700784-001
Catalog Number1700784-001
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 Kittrue
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
HIBCCJ00717007840011 [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

On-Brand Devices [SET BIOPOWER]

J00717007840011Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
J0071700784001E1Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories

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