AccessGUDID - DEVICE: Comfort-Sonic (00990010302020)

GUDID

Device Identifier (DI) Information

Brand Name: Comfort-Sonic
Version or Model: UL2104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Comfort-Sonic LED Scaler P6 Plus
Company Name: Beyes Dental Canada Inc

Primary DI Number: 00990010302020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 244261462 *Terms of Use

Device Description: Comfort-Sonic LED Scaler P6 Plus,Includes 6 tips ( EE1, 2 EG1, EG2, EG4, EP1)

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
36047	Ultrasonic dental scaling/debridement system	An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053555	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: 1b8308b3-e4ed-40c6-a585-f77cd93d0d38
Public Version Date: May 19, 2023
Public Version Number: 1
DI Record Publish Date: May 11, 2023