SEPTODONT N'DURANCE CORE B.U. WHITE 2X9G W/T

GUDID 00303620000987

SEPTODONT, INC

Dental composite resin

• Primary Device ID: 00303620000987
• NIH Device Record Key: 9af6a115-b5a8-4e81-a805-4f8d841fcc41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEPTODONT N'DURANCE CORE B.U. WHITE 2X9G W/T
• Version Model Number: 01C2600
• 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: 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: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com

Device Dimensions

• Weight: 9 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620000987 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-12