AccessGUDID - DEVICE: EXPERTtorque E675 LMW (EKAV100608000)

GUDID

Device Identifier (DI) Information

Brand Name: EXPERTtorque E675 LMW
Version or Model: 1.006.0800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E675 LMW
Company Name: KaVo Dental GmbH

Primary DI Number: EKAV100608000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333710619 *Terms of Use

Device Description: This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.

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?
40958	Dental power tool system handpiece, pneumatic	A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	HANDPIECE, AIR-POWERED, DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073478	000

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
Handling Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bbf06d25-e088-4b45-bea0-5e2b8febe02d
Public Version Date: November 08, 2021
Public Version Number: 6
DI Record Publish Date: September 26, 2016