iSmile 400011

GUDID H6684000111

iSmile Alginate Dustless Regular Set Impression Material Mint (1lb)

Harry J Bosworth Company

Alginate dental impression material

• Primary Device ID: H6684000111
• NIH Device Record Key: 40bc06b2-30c7-4993-ad2d-81553755229c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSmile
• Version Model Number: 400011
• Catalog Number: 400011
• Company DUNS: 014769301
• Company Name: Harry J Bosworth Company
• 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: true
• 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

• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram
• Weight: 1 Pound
• Weight: 454 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water
• Special Storage Condition, Specify: Between 0 and 0 *Store in tightly sealed container
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from humidity. Do not Store in Water

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H6684000111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940402

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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

On-Brand Devices [iSmile]

• H6686050010: iSmile Pit & Fissure Sealant LC w/ Fluoride Syringe
• H6684000121: iSmile Alginate Dustless Fast Set Impression Material Mint (1lb)
• H6684000111: iSmile Alginate Dustless Regular Set Impression Material Mint (1lb)