DEVICE: Cleaning Crystals, Packette (00816063021407)

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Device Record History
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Device Identifier (DI) Information
Cleaning Crystals, Packette
20127
In Commercial Distribution

Align Technology, Inc.
00816063021407
GS1

1
013831768 *Terms of Use
Invisalign Cleaning Crystals
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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?
44736 Orthodontic appliance cleanser
An agent used to remove soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. It is normally used at home by the wearer of the appliance, and is typically supplied as tablets or crystals used to make a solution that removes and/or dissolves debris or accretions. This device may need to be used in conjunction with an electrical or mechanical cleansing device. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EFT Cleanser, Denture, Over The Counter
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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
6c92cc84-e288-4b28-b5af-ef7388e7d08c
September 18, 2025
2
December 06, 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
00816063021162 3 00816063021407 In Commercial Distribution 3 pack
00816063020301 250 00816063021407 In Commercial Distribution bulk 250
00816063020318 50 00816063021407 In Commercial Distribution 50ct kit
00816063021179 50 00816063021407 In Commercial Distribution kit
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Secondary DI

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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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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