AELITE LS A2 15tips/Fex Tube H-722A2F

GUDID D757H722A2F0

BISCO INC.

Dental composite resin

• Primary Device ID: D757H722A2F0
• NIH Device Record Key: 20b3f3a1-6cb9-47d1-b68c-26b85d5de8dc
• Commercial Distribution Discontinuation: 2019-12-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AELITE LS A2 15tips/Fex Tube
• Version Model Number: H-722A2F
• Catalog Number: H-722A2F
• Company DUNS: 053529939
• Company Name: BISCO INC.
• 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: 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: +1(847)534-6000
• Email: sales@bisco.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757H722A2F0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003361

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-06
• Device Publish Date: 2017-06-12

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