AccessGUDID - DEVICE: MECTRON (E322034500041110)

GUDID

Device Identifier (DI) Information

Brand Name: MECTRON
Version or Model: ER4 + K10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03450004-1011
Company Name: MECTRON SPA

Primary DI Number: E322034500041110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436664734 *Terms of Use

Device Description: ER4 is a diamond coated scaling insert intended for endodontic revision treatment and to be used in conjunction with Mectron ultrasonic handpieces. The package includes insert and K10 torque wrench (DI Number E32202900137).

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:	Yes
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?
46035	Ultrasonic dental scaling/debridement system handpiece tip, endodontic	An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a variety of forms and sizes, and is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140965	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: fdf8052d-e47d-4f57-b235-6185a1510d47
Public Version Date: September 20, 2019
Public Version Number: 1
DI Record Publish Date: September 12, 2019