DEVICE: HyFlex EDM (E165600193630)
Device Identifier (DI) Information
HyFlex EDM
60019363
In Commercial Distribution
60019363
Coltène/Whaledent GmbH + Co. KG
60019363
In Commercial Distribution
60019363
Coltène/Whaledent GmbH + Co. KG
HyFlex EDM Shaping Set Simple 25/.12, 10/.05, 25/.~, 25mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
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Yes | |
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No |
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? |
---|---|---|---|---|
40529 | Rotary/reciprocating endodontic file/rasp, reusable |
A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EKS | File, Pulp Canal, Endodontic |
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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Special Storage Condition, Specify: keep dry |
Special Storage Condition, Specify: keep away from sunlight |
Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Storage Environment Temperature: between 37 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1525d707-a065-4c97-92d9-9750d616f55a
December 02, 2024
2
September 22, 2023
December 02, 2024
2
September 22, 2023
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 |
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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
[?]
+4973458050
service@coltene.com
service@coltene.com