SEPTODONT SEPTOBOND BONDIN AGENT 5 mL 01C2030

GUDID 00303620000611

SEPTODONT, INC

Dentine adhesive

• Primary Device ID: 00303620000611
• NIH Device Record Key: 51b0aff0-8ad0-4080-ae39-ade8378d60f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEPTODONT SEPTOBOND BONDIN AGENT 5 mL
• Version Model Number: 01C2030
• Catalog Number: 01C2030
• 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

• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303620000611 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-12

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• 00303620000314 - EARLOOP FACE MASK WHITE 3 PLY (2130): 2020-05-06 MASK E/L WH L1
• 00303620000109 - 2 INCH CLEAR CONT NYL FILM (0002): 2019-11-08 2 INCH CLEAR CONT NYL FILM (0002)
• 00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003): 2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003)