AccessGUDID - DEVICE: OptiSonic™ super-concentrated general purpose ultrasonic cleaning solution (D6870321368FG2)

GUDID

Device Identifier (DI) Information

Brand Name: OptiSonic™ super-concentrated general purpose ultrasonic cleaning solution
Version or Model: 0321368FG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0321368FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6870321368FG2
Issuing Agency: HIBCC
Commercial Distribution End Date: December 27, 2022
Device Count: 6
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: OptiSonic™ super-concentrated tartar & stain remover ultrasonic cleaning solution, Six 16-oz Bettix Bottles

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?
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFT	CLEANSER, DENTURE, OVER THE COUNTER

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
Special Storage Condition, Specify: Do not store below freezing.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 16 Fluid Ounce
Device Size Text, specify: Six 16-oz Bettix Bottles

Device Record Status

Public Device Record Key: ce9d9b93-8686-4a94-a389-a0da54ae7f46
Public Version Date: December 27, 2022
Public Version Number: 5
DI Record Publish Date: September 21, 2016