iSmile 0701377

GUDID H6682030051

iSmile Etch Gel 37% Bulk Syringe (50ml)

Keystone Industries

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: H6682030051
• NIH Device Record Key: aa92001b-4faa-4f8a-acc8-5c8bdeec5b08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSmile
• Version Model Number: 0701377
• Catalog Number: 0701377
• Company DUNS: 073503117
• Company Name: Keystone Industries
• 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(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Device Dimensions

• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H6682030051 [Primary]

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: 2023-02-28
• Device Publish Date: 2023-02-20

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