KROMALGIN Piu 18g 002003

GUDID 38033712560275

Alginate for dental impressions

VANNINI DENTAL INDUSTRY SRL

Alginate dental impression material

• Primary Device ID: 38033712560275
• NIH Device Record Key: 629b9708-f636-401d-98c5-b1dabac59cad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KROMALGIN Piu 18g
• Version Model Number: 002003
• Catalog Number: 002003
• 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: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter
• Total Volume: 27280 Milliliter

Operating and Storage Conditions

• 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
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033712560274 [Primary]
GS1	38033712560275 [Package]; Contains: 08033712560274; Package: BOX [300 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963609

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: 2019-09-27
• Device Publish Date: 2019-09-19

Devices Manufactured by VANNINI DENTAL INDUSTRY SRL

• 38033712560275 - KROMALGIN Piu 18g: 2019-09-27Alginate for dental impressions
• 38033712560275 - KROMALGIN Piu 18g: 2019-09-27 Alginate for dental impressions
• 58033712562709 - PRESTIGE HYDROLIGHT 2X50 ML+12 YELLOW MIXING TIPS: 2019-09-27 Vinylpolisiloxane for impressions
• 18033712560219 - CROMATIC 453g: 2019-09-16 Alginate for dental impressions
• 18033712560226 - KROMALGIN Piu 453g: 2019-09-16 Alginate for dental impressions
• 18033712560233 - CLIPALGIN 453g: 2019-09-16 Alginate for dental impressions
• 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: 2019-09-16 Alginate for dental impressions