Aelite All-Purpose Body H-812B1

GUDID D757H812B10

Aelite All-Purpose Body B1 4g Syringe

BISCO INC.

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• Primary Device ID: D757H812B10
• NIH Device Record Key: 3b6ff4fe-4a84-4e88-a1af-7ee07fcc9fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aelite All-Purpose Body
• Version Model Number: H-812B1
• Catalog Number: H-812B1
• 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: 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: +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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757H812B10 [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: 4
• Public Version Date: 2022-06-03
• Device Publish Date: 2017-06-12

On-Brand Devices [Aelite All-Purpose Body]

• D757H814B1P1: Aelite All-Purpose Body B1 15ct Unit Dose (0.25g ea) Pkg
• D757H814B10: Aelite All-Purpose Body B1 15ct Unit Dose (0.25g ea)
• D757H814A3P1: Aelite All-Purpose Body A3 15ct Unit Dose (0.25g ea) Pkg
• D757H814A35P1: Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea) Pkg
• D757H814A350: Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea)
• D757H814A30: Aelite All-Purpose Body A3 15ct Unit Dose (0.25g ea)
• D757H814A2P1: Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea) Pkg
• D757H814A20: Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea)
• D757H814A1P1: Aelite All-Purpose Body A1 15ct Unit Dose (0.25g ea) Pkg
• D757H814A10: Aelite All-Purpose Body A1 15ct Unit Dose (0.25g ea)
• D757H812B1P1: Aelite All-Purpose Body B1 4g Syringe Pkg
• D757H812B10: Aelite All-Purpose Body B1 4g Syringe
• D757H812A3P1: Aelite All-Purpose Body A3 4g Syringe Pkg
• D757H812A35P1: Aelite All-Purpose Body A3.5 4g Syringe Pkg
• D757H812A350: Aelite All-Purpose Body A3.5 4g Syringe
• D757H812A30: Aelite All-Purpose Body A3 4g Syringe
• D757H812A2P1: Aelite All-Purpose Body A2 4g Syringe Pkg
• D757H812A20: Aelite All-Purpose Body A2 4g Syringe
• D757H812A1P1: Aelite All-Purpose Body A1 4g Syringe Pkg
• D757H812A10: Aelite All-Purpose Body A1 4g Syringe
• 10810111541746: Aelite All-Purpose Body B1 4g Syringe
• 10810111541722: Aelite All-Purpose Body A3 4g Syringe
• 10810111541715: Aelite All-Purpose Body A2 4g Syringe
• 10810111541708: Aelite All-Purpose Body A1 4g Syringe
• 20810111541767: Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea)