Aelite LS Posterior H-722A3

GUDID 20810111541873

Aelite LS Posterior A3 15ct Unit Dose (0.25g ea)

BISCO INC.

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• Primary Device ID: 20810111541873
• NIH Device Record Key: 61f55948-5b67-4afb-84b9-1e49e3f21127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aelite LS Posterior
• Version Model Number: H-722A3
• Catalog Number: H-722A3
• Company DUNS: 053529939
• Company Name: BISCO INC.
• Device Count: 15
• 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
• 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
• 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
• 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
GS1	00810111541879 [Unit of Use]
GS1	10810111541876 [Primary]
GS1	20810111541873 [Package]; Contains: 10810111541876; Package: Item No: H-722A3P [1 Units]; In Commercial Distribution
HIBCC	D757H722A30 [Previous]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-25
• Device Publish Date: 2022-11-17

On-Brand Devices [Aelite LS Posterior]

• D757H722B1P1: Aelite LS Posterior B1 15ct Unit Dose (0.25g ea) Pkg
• D757H722A3P1: Aelite LS Posterior A3 15ct Unit Dose (0.25g ea) Pkg
• D757H722A35P1: Aelite LS Posterior A3.5 15ct Unit Dose (0.25g ea) Pkg
• D757H722A30: Aelite LS Posterior A3 15ct Unit Dose (0.25g ea)
• D757H722A2P1: Aelite LS Posterior A2 15ct Unit Dose (0.25g ea) Pkg
• D757H722A1P1: Aelite LS Posterior A1 15ct Unit Dose (0.25g ea)
• D757H721B1P1: Aelite LS Posterior B1 4g Syringe Pkg
• D757H721B10: Aelite LS Posterior B1 4g Syringe
• D757H721A3P1: Aelite LS Posterior A3 4g Syringe Pkg
• D757H721A35P1: Aelite LS Posterior A3.5 4g Syringe Pkg
• D757H721A350: Aelite LS Posterior A3.5 4g Syringe
• D757H721A30: Aelite LS Posterior A3 4g Syringe
• D757H721A2P1: Aelite LS Posterior A2 4g Syringe Pkg
• D757H721A20: Aelite LS Posterior A2 4g Syringe
• D757H721A1P1: Aelite LS Posterior A1 4g Syringe Pkg
• D757H721A10: Aelite LS Posterior A1 4g Syringe
• D757H722B10: Aelite LS Posterior B1 15ct Unit Dose (0.25g ea)
• D757H722A350: Aelite LS Posterior A3.5 15ct Unit Dose (0.25g ea)
• D757H722A20: Aelite LS Posterior A2 15ct Unit Dose (0.25g ea)
• D757H722A10: Aelite LS Posterior A1 15ct Unit Dose (0.25g ea)
• 10810111541807: Aelite LS Posterior A1 4g Syringe
• 10810111541814: Aelite LS Posterior A2 4g Syringe
• 20810111541866: Aelite LS Posterior A2 15ct Unit Dose (0.25g ea)
• 10810111541845: Aelite LS Posterior B1 4g Syringe
• 10810111541838: Aelite LS Posterior A3.5 4g Syringe
• 10810111541821: Aelite LS Posterior A3 4g Syringe
• 20810111541873: Aelite LS Posterior A3 15ct Unit Dose (0.25g ea)