DEVICE: KATANA™ Zirconia ONE (EKUR1259691KA0)

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Device Record History
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Device Identifier (DI) Information
KATANA™ Zirconia ONE
125-9691KA
In Commercial Distribution

KURARAY NORITAKE DENTAL INC.
EKUR1259691KA0
HIBCC

1
697119498 *Terms of Use
For IMPLANT L A2
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Device Characteristics
MR Conditional
No
No
No
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?
16187 Dental appliance fabrication material, ceramic
A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NHA Abutment, Implant, Dental, Endosseous
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K233285 000
No 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
Device Size Text, specify: Width:22.1 Millimeter
Device Size Text, specify: Height:23.6 Millimeter
Device Size Text, specify: Length:24.6 Millimeter
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Device Record Status
9184d19b-c4ae-4c66-8d5c-da922f1e5c5d
November 29, 2024
1
November 21, 2024
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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