AccessGUDID - DEVICE: TRY-ME DENTASOAK KIT (D7752350241)

GUDID

Device Identifier (DI) Information

Brand Name: TRY-ME DENTASOAK KIT
Version or Model: 235-024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 235-024
Company Name: GREAT LAKES ORTHODONTICS, LTD.

Primary DI Number: D7752350241
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041854332 *Terms of Use

Device Description: TRY-ME DENTASOAK 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:	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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Denture cleanser	An agent 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, e.g., a toothbrush. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

GMDN Preferred Term Name

GMDN Definition

Denture cleanser

An agent 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, e.g., a toothbrush. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f520d587-4edf-407a-b334-89d9dbd1da3c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 18, 2016