PermaFlo 956

GUDID 00883205103871

PermaFlo B1 Refill

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205103871
• NIH Device Record Key: 98520ca8-d78c-42e3-9675-2564f919b7d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermaFlo
• Version Model Number: 956
• Catalog Number: 956
• 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	00883205103871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974413

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 [PermaFlo]

• 00883205104113: PermaFlo Advanced Kit
• 00883205104052: PermaFlo Dentin Opaquer Refill
• 00883205103925: PermaFlo A1 Refill
• 00883205103918: PermaFlo A2 Refill
• 00883205103901: PermaFlo A3 Refill
• 00883205103895: PermaFlo A3.5 Refill
• 00883205103888: PermaFlo A4 Refill
• 00883205103871: PermaFlo B1 Refill
• 00883205103864: PermaFlo Purple 2 Syr Kit Unv
• 00883205103857: PermaFlo Pink Kit
• 00883205103727: PermaFlo Translucent Refill
• 00883205102591: PermaFlo A2 Unit Dose 50pk