DEVICE: TRY-ME DENTASOAK KIT (D7752350241)
Device Identifier (DI) Information
TRY-ME DENTASOAK KIT
235-024
In Commercial Distribution
235-024
GREAT LAKES ORTHODONTICS, LTD.
235-024
In Commercial Distribution
235-024
GREAT LAKES ORTHODONTICS, LTD.
TRY-ME DENTASOAK KIT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]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. |
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f520d587-4edf-407a-b334-89d9dbd1da3c
March 29, 2018
2
May 18, 2016
March 29, 2018
2
May 18, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-828-7626
info@greatlakesortho.com
info@greatlakesortho.com