SCOTT'S SELECT 37% ETCH GEL 12gm BULK SYRINGE KIT 199-1012

GUDID D77819910121

SCOTT'S DENTAL SUPPLY L.L.C.

Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution Dental etching solution

• Primary Device ID: D77819910121
• NIH Device Record Key: a661a725-ffa1-4d89-8780-cfb0b8641850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCOTT'S SELECT 37% ETCH GEL 12gm BULK SYRINGE KIT
• Version Model Number: 199-1012
• Catalog Number: 199-1012
• Company DUNS: 137217043
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8009013368
• Email: info@scottsdental.com
• Phone: 8009013368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com
• Phone: +1(800)901-3368
• Email: info@scottsdental.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77819910121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150696

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: 3
• Public Version Date: 2019-03-11
• Device Publish Date: 2017-05-24