SEPTODONT N'DURANCE FLOW 2-2G A3.5

GUDID 00303620001267

SEPTODONT, INC

Dental composite resin

• Primary Device ID: 00303620001267
• NIH Device Record Key: 49a8be50-d1db-4898-b00a-ae8d4ff7d3ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEPTODONT N'DURANCE FLOW 2-2G A3.5
• Version Model Number: 01C3083
• Company DUNS: 012925513
• Company Name: SEPTODONT, 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: true
• 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: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com

Device Dimensions

• Weight: 2 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620001267 [Primary]

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: 2018-06-19
• Device Publish Date: 2016-09-12