123-Align

GUDID 00860006415495

U Smile Dental LLC

Dental impression material kit, single-use

• Primary Device ID: 00860006415495
• NIH Device Record Key: dfa2f7bc-64e9-46e8-9bd4-9d696f146f28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 123-Align
• Version Model Number: 12021
• Company DUNS: 081162949
• Company Name: U Smile Dental LLC
• 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: true
• Lot Batch: false
• Serial Number: false
• 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	00860006415495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133071

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-03
• Device Publish Date: 2021-05-24

On-Brand Devices [123-Align]

• 90860006415429: LX-A
• 00860006415488: 12021
• 00860006415495: 12021