Thermo Clone 4329

GUDID 00883205109019

Thermo Clone VPS Fast Alginate Alternative 380 ml Kit

ULTRADENT PRODUCTS, INC.

Silicone dental impression material

• Primary Device ID: 00883205109019
• NIH Device Record Key: 775fef6c-e9ef-42ee-8342-5cfccb514959
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Clone
• Version Model Number: 4329
• Catalog Number: 4329
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: false
• 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(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205109019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082157

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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [Thermo Clone]

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• 00883205105370: Thermo Clone VPS Tray Adhesive 10ml
• 00883205027375: Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack
• 00883205027368: Thermo Clone VPS Fast Set Light Body 10x50 ml Bulk Pack
• 00883205032430: Thermo Clone VPS Clear Bite Registration Fast Set 2x50 ml Kit
• 00883205033710: Thermo Clone VPS Fast Alginate Alternative 380 ml Kit
• 00883205033703: Thermo Clone VPS Alginate Alternative 10x50 ml Bulk Pack
• 00883205033697: Thermo Clone VPS Alginate Alternative 2x50 ml Kit
• 00883205031693: Thermo Clone VPS Dynamic Mixer 50ct
• 00883205031686: Thermo Clone VPS Tray Adhesive 10ml
• 00883205109019: Thermo Clone VPS Fast Alginate Alternative 380 ml Kit
• 00883205031716: Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack
• 00883205031709: Thermo Clone VPS Fast Set Light Body 10x50 ml Bulk Pack