Reveal HD Bulk H-9334B1

GUDID 40810111542638

Reveal HD Bulk B1 50ct Unit Dose (0.25g ea)

BISCO INC.

Dental composite resin

• Primary Device ID: 40810111542638
• NIH Device Record Key: b0644b0e-baea-4bb4-ba7e-dd0deded8ae6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reveal HD Bulk
• Version Model Number: H-9334B1
• Catalog Number: H-9334B1
• Company DUNS: 053529939
• Company Name: BISCO INC.
• Device Count: 50
• 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	00810111542630 [Unit of Use]
GS1	30810111542631 [Primary]
GS1	40810111542638 [Package]; Contains: 30810111542631; Package: Item No: H-9334B1P [1 Units]; In Commercial Distribution
HIBCC	D757H9334B10 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171147

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 [Reveal HD Bulk]

• D757H933B10: Reveal HD Bulk B1 Unit Dose (0.25g)
• D757H933A30: Reveal HD Bulk A3 Unit Dose (0.25g)
• D757H933A20: Reveal HD Bulk A2 Unit Dose (0.25g)
• D757H933A10: Reveal HD Bulk A1 Unit Dose (0.25g)
• D757H9334B1P0: Reveal HD Bulk B1 50ct Unit Dose (0.25g ea) Pkg
• D757H9334B10: Reveal HD Bulk B1 50ct Unit Dose (0.25g ea)
• D757H9334A3P1: Reveal HD Bulk A3 50ct Unit Dose (0.25g ea) Pkg
• D757H9334A30: Reveal HD Bulk A3 50ct Unit Dose (0.25g ea)
• D757H9334A2P1: Reveal HD Bulk A2 50ct Unit Dose (0.25g ea) Pkg
• D757H9334A20: Reveal HD Bulk A2 50ct Unit Dose (0.25g ea)
• D757H9334A1P1: Reveal HD Bulk A1 50ct Unit Dose (0.25g ea) Pkg
• D757H9334A10: Reveal HD Bulk A1 50ct Unit Dose (0.25g ea)
• D757H9332B1P1: Reveal HD Bulk B1 25ct Unit Dose (0.25g ea) Pkg
• D757H9332B10: Reveal HD Bulk B1 25ct Unit Dose (0.25g ea)
• D757H9332A3P1: Reveal HD Bulk A3 25ct Unit Dose (0.25g ea) Pkg
• D757H9332A30: Reveal HD Bulk A3 25ct Unit Dose (0.25g ea)
• D757H9332A2P1: Reveal HD Bulk A2 25ct Unit Dose (0.25g ea) Pkg
• D757H9332A20: Reveal HD Bulk A2 25ct Unit Dose (0.25g)
• D757H9332A1P1: Reveal HD Bulk A1 25ct Unit Dose (0.25g ea) Pkg
• D757H9332A10: Reveal HD Bulk A1 25ct Unit Dose (0.25g ea)
• D757H9330A2PS1: Reveal HD Bulk A2 3ct Unit Dose Pkg
• D757H931B1P1: Reveal HD Bulk B1 3g Syringe Pkg
• D757H931B10: Reveal HD Bulk B1 3g Syringe
• D757H931A3P1: Reveal HD Bulk A3 3g Syringe Pkg
• D757H931A30: Reveal HD Bulk A3 3g Syringe
• D757H931A2P1: Reveal HD Bulk A2 3g Syringe Pkg
• D757H931A20: Reveal HD Bulk A2 3g Syringe
• D757H931A1P1: Reveal HD Bulk A1 3g Syringe Pkg
• D757H931A10: Reveal HD Bulk A1 3g Syringe
• 10810111542569: Reveal HD Bulk A1 3g Syringe
• 30810111542617: Reveal HD Bulk A2 25ct Unit Dose (0.25g)
• 20810111542634: Reveal HD Bulk B1 25ct Unit Dose (0.25g ea)
• 20810111542627: Reveal HD Bulk A3 25ct Unit Dose (0.25g ea)
• 10810111542590: Reveal HD Bulk B1 3g Syringe
• 20810111542603: Reveal HD Bulk A1 25ct Unit Dose (0.25g ea)
• 10810111542583: Reveal HD Bulk A3 3g Syringe
• 10810111542576: Reveal HD Bulk A2 3g Syringe
• 50810111542611: Reveal HD Bulk A2 50ct Unit Dose (0.25g ea)
• 40810111542607: Reveal HD Bulk A1 50ct Unit Dose (0.25g ea)
• 40810111542638: Reveal HD Bulk B1 50ct Unit Dose (0.25g ea)