AccessGUDID - DEVICE: IDUP board (J00716011960051)

GUDID

Device Identifier (DI) Information

Brand Name: IDUP board
Version or Model: 1601196-005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bien-Air Dental SA

Primary DI Number: J00716011960051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480082080 *Terms of Use

Device Description: integrable devices are electronic boards that allow the control of Bien-Air Electric micromotors as well as various dental instruments. They are intended to be integrated into a dental unit (kart or dental chair). iOPTIMA INT and Integrated Dental Unit Platform (IDUP) are dental chair’s integrated device allowing the control of dental and surgical micromotors parameters (such as torque, speed, and direction of rotation), irrigation pump and dental accessories via a user interface. For iOptima INT devices, the user interface is and Apple Device.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41264	Surgical power tool system control unit, line-powered	A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4500532e-2236-4a2d-9c03-109e089d7c9a
Public Version Date: September 19, 2023
Public Version Number: 1
DI Record Publish Date: September 11, 2023