Thermo Clone VPS 4058-

GUDID 00883205105257

Thermo Clone VPS Medium Body 2x50 ml Refill Kit

ULTRADENT PRODUCTS, INC.

Silicone dental impression material

• Primary Device ID: 00883205105257
• NIH Device Record Key: da6c2015-9b48-4424-a89d-1a0a82c0401a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Clone VPS
• Version Model Number: 4058-
• Catalog Number: 4058-
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205105257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082560

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-11-04

On-Brand Devices [Thermo Clone VPS]

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• 00883205105356: Thermo Clone Fast Set Bite Registration 2x50 ml Kit
• 00883205105349: Thermo Clone VPS Fast Set Heavy Body 380 ml Kit
• 00883205105332: Thermo Clone VPS Fast Set Medium Body 380 ml Kit
• 00883205105325: Thermo Clone VPS Heavy Body 380 ml Kit
• 00883205105318: Thermo Clone VPS Medium Body 380 ml Kit
• 00883205105301: Thermo Clone VPS Fast Set Heavy Body 2x50 ml Refill Kit
• 00883205105295: Thermo Clone VPS Fast Set Medium Body 2x50 ml Refill Kit
• 00883205105288: Thermo Clone VPS Fast Set Light Body 2x50 ml Refill Kit
• 00883205105271: Thermo Clone VPS Fast Set Superlight Body 2x50 ml Refill Kit
• 00883205105264: Thermo Clone VPS Heavy Body 2x50 ml Refill Kit
• 00883205105257: Thermo Clone VPS Medium Body 2x50 ml Refill Kit
• 00883205105240: Thermo Clone VPS Light Body 2x50 ml Refill Kit