Thermo Clone 4077

GUDID 00883205027375

Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack

ULTRADENT PRODUCTS, INC.

Silicone dental impression material

• Primary Device ID: 00883205027375
• NIH Device Record Key: cc48154f-6363-4ee3-afbd-83a92820d05b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Clone
• Version Model Number: 4077
• Catalog Number: 4077
• 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	00883205027375 [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: 2
• Public Version Date: 2019-11-11
• Device Publish Date: 2018-09-19

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