AccessGUDID - DEVICE: XPU MMOTOR LIGHT (J00716012420011)

GUDID

Device Identifier (DI) Information

Brand Name: XPU MMOTOR LIGHT
Version or Model: 1601242-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bien-Air Dental SA

Primary DI Number: J00716012420011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480407528 *Terms of Use

Device Description: The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedicated bur fixed to an adequate contra-angle or straight handpiece for different clinical applications. The micromotor connected to a cable or a hose depending on the type (the hose integrates water and air connection) is driven using an electronic control either integrated in a dental console or a dental unit.

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?
66227	Dental surgical power tool motor, electric	A hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, 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 [?]
Ethylene Oxide

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: e79a49f9-0bdd-4c21-bb67-2f930224e48e
Public Version Date: May 02, 2024
Public Version Number: 1
DI Record Publish Date: April 24, 2024