AccessGUDID - DEVICE: RETAINER BRITE® (D746RB120CASE1)

GUDID

Device Identifier (DI) Information

Brand Name: RETAINER BRITE®
Version or Model: RB120CASE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RB120CASE
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D746RB120CASE1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: Retainer Brite® Cleaning Tablets 120 ct case

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
44736	Orthodontic appliance cleanser	An agent used to remove soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. It is normally used at home by the wearer of the appliance, and is typically supplied as tablets or crystals used to make a solution that removes and/or dissolves debris or accretions. This device may need to be used in conjunction with an electrical or mechanical cleansing device. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 292b1b82-ddae-4ca8-a887-6f19af0d775a
Public Version Date: March 28, 2024
Public Version Number: 2
DI Record Publish Date: May 01, 2021