PROTESIL ELASTIC RAPID 500g 005002

GUDID 48033712560319

Alginate for dental impressions

VANNINI DENTAL INDUSTRY SRL

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: 48033712560319
• NIH Device Record Key: de927c00-f868-41b2-b1a2-2464e35a9d93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROTESIL ELASTIC RAPID 500g
• Version Model Number: 005002
• Catalog Number: 005002
• Company DUNS: 436650394
• Company Name: VANNINI DENTAL INDUSTRY SRL
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com
• Phone: +39055644698
• Email: info@vanninidental.com

Device Dimensions

• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter
• Total Volume: 38480 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handling Environment Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033712560311 [Primary]
GS1	48033712560319 [Package]; Contains: 08033712560311; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043118

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: 2019-09-16
• Device Publish Date: 2019-09-06

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• 38033712560251 - CLIPALGIN 18 g: 2019-09-16 Alginate for dental impressions
• 38033712560268 - CROMATIC 18 g: 2019-09-16 Alginate for dental impressions
• 48033712560319 - PROTESIL ELASTIC RAPID 500g: 2019-09-16Alginate for dental impressions
• 48033712560319 - PROTESIL ELASTIC RAPID 500g: 2019-09-16 Alginate for dental impressions