Aelite LS Posterior H-721A35

GUDID 10810111541838

Aelite LS Posterior A3.5 4g Syringe

BISCO INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 10810111541838
• NIH Device Record Key: 2b7f95fa-341b-4015-a480-3edf4523d400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aelite LS Posterior
• Version Model Number: H-721A35
• Catalog Number: H-721A35
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111541831 [Primary]
GS1	10810111541838 [Package]; Contains: 00810111541831; Package: Item No: H-721A35P [1 Units]; In Commercial Distribution
HIBCC	D757H721A350 [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: 2022-10-18
• Device Publish Date: 2022-10-10

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)