iSmile 400011

GUDID H6684000111

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

Harry J Bosworth Company

Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material Alginate dental impression material 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

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• H6684000111: iSmile Alginate Dustless Regular Set Impression Material Mint (1lb)