ClearTemp LC S3518

GUDID 00883205102744

Sample ClearTemp LC Temporary Veneer Cement

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205102744
• NIH Device Record Key: a85fc214-07ba-4b54-9ab8-44bfd918688f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearTemp LC
• Version Model Number: S3518
• Catalog Number: S3518
• 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: true
• Device Combination Product: false
• Single Use: true
• 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 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205102744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111017

FDA Product Code

• EMA: CEMENT, DENTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [ClearTemp LC]

• 00883205106674: ClearTemp LC Temporary Veneer Cement Refill
• 00883205102744: Sample ClearTemp LC Temporary Veneer Cement