IMPRESS

GUDID 06956748701614

Wuxi EA Medical Instruments Technologies Limited.

Orthodontic progressive aligner

• Primary Device ID: 06956748701614
• NIH Device Record Key: db790205-08af-4aed-87b5-74a33e6dbc4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPRESS
• Version Model Number: EAB II
• Company DUNS: 421315681
• Company Name: Wuxi EA Medical Instruments Technologies Limited.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	06956748701614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223517

FDA Product Code

• NXC: Aligner, Sequential

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: 2023-12-14
• Device Publish Date: 2023-12-06

Devices Manufactured by Wuxi EA Medical Instruments Technologies Limited.

• 06956748701614 - IMPRESS: 2023-12-14
• 06956748701614 - IMPRESS: 2023-12-14
• 06956748701270 - angel aligner: 2023-07-03
• 06956748700495 - angel aligner Classic: 2022-07-08