DEVICE: Dental City (D77139400)

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Device Record History
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Device Identifier (DI) Information
Dental City
39-400
In Commercial Distribution

ICP, INC.
D77139400
HIBCC

6
808371371 *Terms of Use
K-Files 25mm #15
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
63721 Endodontic enlarger, single-use
A non-sterile manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKQ Preparer, Root 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
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
7be12e40-0f16-4d82-b3e3-b526e8429247
July 23, 2021
1
July 15, 2021
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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: D771394000 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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