Thermo Clone VPS 4060

GUDID 00883205105271

Thermo Clone VPS Fast Set Superlight Body 2x50 ml Refill Kit

ULTRADENT PRODUCTS, INC.

Silicone dental impression material

• Primary Device ID: 00883205105271
• NIH Device Record Key: 88626d7f-a24a-47ae-9956-eb32264566df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Clone VPS
• Version Model Number: 4060
• Catalog Number: 4060
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205027344 [Primary]
GS1	00883205105271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083701

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-04

On-Brand Devices [Thermo Clone VPS]

• 00883205105363: Thermo Clone VPS Putty Fast Set 2x200 ml Kit
• 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