DEVICE: X-Factor™ Minimally Invasive NiTi Files 25/.04 (21mm) (07540172013147)

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Device Record History
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Device Identifier (DI) Information
X-Factor™ Minimally Invasive NiTi Files 25/.04 (21mm)
311009
In Commercial Distribution
311009
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
07540172013147
GS1

1
626406016 *Terms of Use
Endodontic surgical files
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKS FILE, PULP CANAL, ENDODONTIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 21 Millimeter
Device Size Text, specify: 6 x 21mm Niti File
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Device Record Status
d0806d97-365a-4c25-bcb1-92b9c6bff500
March 25, 2020
1
March 17, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)265-3444
info@clinicianschoice.com
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