Direct Composite S130-

GUDID 00883205015570

SAMPLE DIRECT COMP HANDS ON

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205015570
• NIH Device Record Key: ed6f8f96-eb75-4a88-ac91-71233b9a2025
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Composite
• Version Model Number: S130-
• Catalog Number: S130-
• 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	00883205015570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974282

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

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: 2018-10-01
• Device Publish Date: 2018-08-31

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