AccessGUDID - DEVICE: Cordless Sonic Cleaner (D746RBUSC1)

GUDID

Device Identifier (DI) Information

Brand Name: Cordless Sonic Cleaner
Version or Model: RB-USC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RB-USC
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D746RBUSC1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: Cordless Sonic Cleaner

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:	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?
44734	Orthodontic appliance automated cleaner	An electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JER	CLEANER, DENTURE, MECHANICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6415c31b-6aa6-4ccc-9f41-b1b681636b05
Public Version Date: October 30, 2023
Public Version Number: 2
DI Record Publish Date: June 13, 2023