AlignerFlow LC 1526

GUDID E22115261

AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe 2x2g A1

VOCO GmbH

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• Primary Device ID: E22115261
• NIH Device Record Key: 862ecbe4-65be-4e9c-8ab9-6a7b826c4291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlignerFlow LC
• Version Model Number: 1526
• Catalog Number: 1526
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22115261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231817

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

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

On-Brand Devices [AlignerFlow LC]

• E22115291: AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta
• E22115281: AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta
• E22115271: AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta
• E22115261: AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner atta