AccessGUDID - DEVICE: MECTRON (E322031202171010)

GUDID

Device Identifier (DI) Information

Brand Name: MECTRON
Version or Model: PIEZOSURGERY GP HANDPIECE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03120217-101
Company Name: MECTRON SPA

Primary DI Number: E322031202171010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436664734 *Terms of Use

Device Description: Ultrasonic Dental Handpiece

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?
44907	Ultrasonic dental scaling/debridement system handpiece	A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.	Active	false
47014	Dental ultrasonic surgical system handpiece	A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic
DZI	Drill, Bone, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151248	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba862d7d-669d-4159-950f-6d13d75e26fb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016