DEVICE: Plasdent (D832XRFAS1)

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Device Record History
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Device Identifier (DI) Information
Plasdent
XR-FAS
In Commercial Distribution
XR-FAS
PLASDENT CORPORATION
D832XRFAS1
HIBCC

25
190377184 *Terms of Use
Complete Aligning System, 4 Arms, 4 Rings, 17 Bite Blocks
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
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?
31828 Dental x-ray system beam alignment device
A mechanical device that is used to support and position dental x-ray film and to serve as a guide for proper physical alignment of the x-ray tube with the positioned dental x-ray film during dental x-ray imaging procedures. Depending on the device design, it can be used as a guide for either intraoral or extraoral dental x-ray systems.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NRD Unit, Operative Dental, Accessories
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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
c12f1761-2997-43d6-84cd-8cf105826b57
February 22, 2022
1
February 14, 2022
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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: D832XRFAS0 CLOSE

Direct Marking (DM)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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