PermaSeal 1013

GUDID 00883205104045

PermaSeal Mini Kit

ULTRADENT PRODUCTS, INC.

Dental unfilled resin sealant/coating

• Primary Device ID: 00883205104045
• NIH Device Record Key: 30696c87-d976-4a11-a637-2fa5956d369f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermaSeal
• Version Model Number: 1013
• Catalog Number: 1013
• 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 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205104045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950859

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, 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

On-Brand Devices [PermaSeal]

• 00883205104045: PermaSeal Mini Kit
• 00883205103703: PermaSeal Refill
• 00883205102584: PermaSeal Unit Dose 50pk