PRESTIGE HYDROLIGHT 2X50 ML+12 YELLOW MIXING TIPS 055107

GUDID 58033712562709

Vinylpolisiloxane for impressions

VANNINI DENTAL INDUSTRY SRL

Silicone dental impression material

• Primary Device ID: 58033712562709
• NIH Device Record Key: d3337fd8-7c79-48f2-9d45-8e02cb2ed8df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESTIGE HYDROLIGHT 2X50 ML+12 YELLOW MIXING TIPS
• Version Model Number: 055107
• Catalog Number: 055107
• 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: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 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	08033712562704 [Primary]
GS1	58033712562709 [Package]; Contains: 08033712562704; Package: BOX [29 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083739

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

On-Brand Devices [PRESTIGE HYDROLIGHT 2X50 ML+12 YELLOW MIXING TIPS]

• 58033712562709: Vinylpolisiloxane for impressions
• 00803371256256: Vinylpolisiloxane for impressions