ExperTemp 6347

GUDID 00883205032058

ExperTemp A3 kit

ULTRADENT PRODUCTS, INC.

Preformed dental crown, temporary

• Primary Device ID: 00883205032058
• NIH Device Record Key: 7a0519d0-c732-498e-b294-21e14ed99085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExperTemp
• Version Model Number: 6347
• Catalog Number: 6347
• 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: 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
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205032058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122039

FDA Product Code

• EBG: CROWN AND BRIDGE, TEMPORARY, 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: 2025-09-01
• Device Publish Date: 2025-08-23

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• 00883205031990: ExperTemp A1 kit
• 00883205031983: ExperTemp A2 kit