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

GUDID D77819910121

SCOTT'S DENTAL SUPPLY L.L.C.

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