AccessGUDID - DEVICE: Cavitron® (D00388001011)

GUDID

Device Identifier (DI) Information

Brand Name: Cavitron®
Version or Model: 8800101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dentsply Professional

Primary DI Number: D00388001011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144140845 *Terms of Use

Device Description: Cavitron® integrated systems Built-In Ultrasonic Scaler Model G139 Dealer Kit (66 GRAY, S/M 360) Also contains: Handpiece with swivel cable, Ultrasonic insert, Installation kit.

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:	Yes
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 [?]
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 75 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Atmospheric limitations 500 to 1060 hPa. Do not place on or next to a radiator or other heat source.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd54e71d-5a2e-4127-8312-3f9735b26447
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016