Uni-Etch E-5637E

GUDID 00810111541039

Uni-Etch (32% Phosphoric Acid Etchant) 30gm Btl Pkg

BISCO INC.

Dental etching solution

• Primary Device ID: 00810111541039
• NIH Device Record Key: e09d5e81-7285-4c8b-9739-e7e63017c10a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-Etch
• Version Model Number: E-5637E
• Catalog Number: E-5637E
• 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: 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
• 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	00810111541039 [Primary]
HIBCC	D757E5637E1 [Previous]

FDA Product Code

• KLE: AGENT, TOOTH BONDING, 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 [Uni-Etch]

• D757E5632EM1: Uni-Etch (32% Phosphoric Acid Etchant) 5g Syr Pkg
• D757E5622E0: Uni-Etch (32% Phosphoric Acid Etchant) 5g Syr
• D757E5502EM1: Uni-Etch (32% Phosphoric Acid Etchant) 4-Syr Pkg
• 00810111541039: Uni-Etch (32% Phosphoric Acid Etchant) 30gm Btl Pkg
• 00810111541022: Uni-Etch (32% Phosphoric Acid Etchant) 4-Syr Pkg
• 00810111541015: Uni-Etch (32% Phosphoric Acid Etchant) 5g Syr Pkg
• 00810111541008: Uni-Etch (32% Phosphoric Acid Etchant) 5g Syr