Novocol EXACTON HARD CHRSD RELINE PWD/LIQ

GUDID 07540187001450

SEPTODONT, INC

Denture reliner, elastic, short-term

• Primary Device ID: 07540187001450
• NIH Device Record Key: 1c420eb8-b8d9-4285-a915-a2f5eaed8b16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novocol EXACTON HARD CHRSD RELINE PWD/LIQ
• Version Model Number: FP-NOVOINC-125
• Company DUNS: 012925513
• Company Name: SEPTODONT, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540187001450 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2018-08-09
• Device Publish Date: 2016-09-12

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