DEVICE: Digital Orthodontic Care (D918DOCWT0)

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Device Record History
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Device Identifier (DI) Information
Digital Orthodontic Care
DOCWT
In Commercial Distribution

Digital Orthodontic Care
D918DOCWT0
HIBCC

1
203697156 *Terms of Use
No description.
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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?
63997 Orthodontic appliance positioning tray
A custom-made dental device in the form of a patient’s dentition with slots/sockets intended to position and hold in place a set of orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) [not included] to bond them to teeth during a single procedure; the orthodontic appliances are loaded onto the device by the orthodontist prior to the procedure. Also known as an indirect bonding tray, it is typically made of synthetic polymer materials and is manufactured from an oral cavity impression or oral scan for a specific patient. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QJJ Indirect Bonding Tray
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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
7a1ab4d0-4a0d-4653-9702-e6f80e46b1c2
December 19, 2022
1
December 09, 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: 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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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