ExperTemp 6347

GUDID 00883205107879

ExperTemp A3 kit

ULTRADENT PRODUCTS, INC.

Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary

• Primary Device ID: 00883205107879
• NIH Device Record Key: 0b8601cd-a667-4a1f-a3eb-acf5d9b2b665
• 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
• 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
• 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
• 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
• 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
• 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
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205107879 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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