Universal Dentin Sealant 265

GUDID 00883205103338

Universal Dentin Sealant Kit

ULTRADENT PRODUCTS, INC.

Dental coating, tooth-desensitizing

• Primary Device ID: 00883205103338
• NIH Device Record Key: 6da4ceab-04c4-4445-b97d-3fd04137cddc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Dentin Sealant
• Version Model Number: 265
• Catalog Number: 265
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205103338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963979

FDA Product Code

• LBH: VARNISH, CAVITY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-22

On-Brand Devices [Universal Dentin Sealant]

• 00883205104014: Universal Dentin Sealant Mini Kit Universal
• 00883205103338: Universal Dentin Sealant Kit
• 00883205103321: Universal Dentin Sealant Refill Universal