Aelite LS Posterior H-722B1P

GUDID D757H722B1P1

Aelite LS Posterior B1 15ct Unit Dose (0.25g ea) Pkg

BISCO INC.

Dental composite resin

• Primary Device ID: D757H722B1P1
• NIH Device Record Key: bb201eb2-3eb9-487a-9d27-556f9a182d0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aelite LS Posterior
• Version Model Number: H-722B1P
• Catalog Number: H-722B1P
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757H722B1P1 [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: 5
• Public Version Date: 2022-06-03
• Device Publish Date: 2017-06-12

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)