PermaFlo DC 1318

GUDID 00883205106223

PermaFlo DC Indirect Luting Regular Set Kit

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205106223
• NIH Device Record Key: 93df8cf3-59b9-4988-8d8e-2deebf8bcf7d
• Commercial Distribution Discontinuation: 2018-09-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PermaFlo DC
• Version Model Number: 1318
• Catalog Number: 1318
• 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	00883205106223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960696

FDA Product Code

• KLE: AGENT, TOOTH BONDING, 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: 4
• Public Version Date: 2018-09-05
• Device Publish Date: 2016-09-22

On-Brand Devices [PermaFlo DC]

• 00883205106841: PermaFlo DC Opaque White Reg. Refill
• 00883205106834: PermaFlo DC Trans Reg Refill
• 00883205106827: PermaFlo DC A3.5 Reg Refill
• 00883205106810: PermaFlo DC A2 Reg Refill
• 00883205106230: PermaFlo DC Bonded Post Regular Set Kit
• 00883205106223: PermaFlo DC Indirect Luting Regular Set Kit