Septodont-250mL bottle 3% NaOCl

GUDID 10818207020601

Vista Dental

Root canal cleaning solution

• Primary Device ID: 10818207020601
• NIH Device Record Key: cbafe9a9-b2e5-4706-9b7b-64082a18d988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Septodont-250mL bottle 3% NaOCl
• Version Model Number: 317050-25
• Company DUNS: 036623932
• Company Name: Vista Dental
• 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: false
• 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: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207020601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082470

FDA Product Code

• KJJ: Cleanser, Root Canal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-08
• Device Publish Date: 2021-01-29

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• 10818207024852 - Vista MST Visco Tip SS 17mm 20/cup: 2023-10-10
• 10818207024869 - Vista MST Visco Tip SS 22mm 20/cup: 2023-10-10
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