AccessGUDID - DEVICE: Cavitron® (D003815131)

GUDID

Device Identifier (DI) Information

Brand Name: Cavitron®
Version or Model: 81513
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dentsply Professional

Primary DI Number: D003815131
Issuing Agency: HIBCC
Commercial Distribution End Date: November 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 144140845 *Terms of Use

Device Description: Bellissima® FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K (B) FSI®-SLI® 3-Pack. Contains: one 30K FSI-SLI 10R, one 30K FSI-SLI 10L, one 30K FSI-SLI 10S

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):	No
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?
44908	Ultrasonic dental scaling/debridement system handpiece tip, periodontal	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 the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. 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 [?]
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: 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: b9aada52-9d2a-43b1-9920-d7dc09d4bba7
Public Version Date: November 30, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016