DEVICE: EDTA (00818365020058)
Device Identifier (DI) Information
EDTA
EEEDTA
In Commercial Distribution
EDGE ENDO LLC
EEEDTA
In Commercial Distribution
EDGE ENDO LLC
EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures to remove the smear layer.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34524 | Dental tooth-cleaning solution |
A liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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KJJ | Cleanser, Root Canal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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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Total Volume: 480 Milliliter |
Device Record Status
68647e55-5fe3-4058-8783-2060d46b957c
October 05, 2018
3
September 28, 2017
October 05, 2018
3
September 28, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined