AELITE All Purpose Body A1O UD H-814A1OP

GUDID D757H814A1OP1

BISCO INC.

Dental composite resin

• Primary Device ID: D757H814A1OP1
• NIH Device Record Key: 45be27ff-a75a-4a03-b274-a86364e9c23d
• Commercial Distribution Discontinuation: 2022-01-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AELITE All Purpose Body A1O UD
• Version Model Number: H-814A1OP
• Catalog Number: H-814A1OP
• 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: true
• 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
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757H814A1OP1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982729

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: 5
• Public Version Date: 2022-01-31
• Device Publish Date: 2017-06-12

Devices Manufactured by BISCO INC.

• 00810111543323 - Quantium: 2025-08-06 Quantium A2 Body 1g Syringe
• 00810111543330 - Quantium: 2025-08-06 Quantium A2 Enamel 1g Syringe
• 00810111543347 - Quantium: 2025-08-06 Quantium A2 Body & A2 Enamel Syringe (1g each) Sample Package
• 10810111541500 - Aelite Aesthetic Enamel: 2025-07-30 Aelite Aesthetic Enamel B4 Syringe
• 10810111541548 - Aelite Aesthetic Enamel: 2025-07-30 Aelite Aesthetic Enamel Incisal Frost Syringe
• 10810111542255 - eCement: 2025-07-30 eCement LC A1 4.5g Syringe
• 20810111541606 - Aelite Aesthetic Enamel: 2025-07-30 Aelite Aesthetic Enamel A4 15ct Unit Dose (0.25g ea)
• 20810111541637 - Aelite Aesthetic Enamel: 2025-07-30 Aelite Aesthetic Enamel B3 15ct Unit Dose (0.25g ea)