DEVICE: 2Shape Mini (J015209532111)
Device Identifier (DI) Information
2Shape Mini
TS1 n25 4% L25 Classics sterile
In Commercial Distribution
20953211
MICRO MEGA
TS1 n25 4% L25 Classics sterile
In Commercial Distribution
20953211
MICRO MEGA
Endodontic instrument for professionnal dental use only
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
61cf606a-7168-4c06-b83a-a1aca800c62f
September 29, 2022
1
September 21, 2022
September 29, 2022
1
September 21, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
J015209532119 | 10 | J015209532111 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
J015209532110
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined