Invisalign Impression Tray Small Lower

GUDID 00816063020417

Small PVS Lower Tray

Align Technology, Inc.

Dental impression tray, single-use

• Primary Device ID: 00816063020417
• NIH Device Record Key: 96bdf8a6-3a7e-455e-819d-29be8ba3f3dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invisalign Impression Tray Small Lower
• Version Model Number: 2569
• Company DUNS: 013831768
• Company Name: Align Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063020417 [Primary]

FDA Product Code

• EHY: Tray, Impression, Preformed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

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• 00816063021452 - iTero Lumina DOA Cart: 2024-02-09 Replacement package of iTero Lumina scanner in case of DOA
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• 00816063021483 - iTero Lumina 25 Disposable Sleeves Box: 2024-02-09 Disposable single use sleeves box
• 00816063021599 - iTero Lumina scanning unit: 2024-02-09 Scanning unit (wand)