Aqua-Prep F B-2824

GUDID D757B28240

Aqua-Prep F 30ml Bottle

BISCO INC.

Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional

• Primary Device ID: D757B28240
• NIH Device Record Key: 63c309f8-14af-49d9-8fa8-93a270776e31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aqua-Prep F
• Version Model Number: B-2824
• Catalog Number: B-2824
• 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

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	D757B28240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961822

FDA Product Code

• KLE: AGENT, TOOTH BONDING, 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 [Aqua-Prep F]

• D757B2824P1: Aqua-Prep F 30ml Bottle Pkg
• D757B28240: Aqua-Prep F 30ml Bottle
• D757B2822P1: Aqua-Prep F 6ml Bottle Pkg
• D757B28220: Aqua-Prep F 6ml Bottle
• 00810111542517: Aqua-Prep F 30ml Bottle Pkg
• 10810111542507: Aqua-Prep F 6ml Bottle