3% NaOCL Sodium Hypochlorite

GUDID 10818207020397

For the debridement and irrigation of root canals during and after instrumentation. 16 ounce bottle.

Vista Dental

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• Primary Device ID: 10818207020397
• NIH Device Record Key: 1d133976-d7cf-4430-9549-56c3f270d040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3% NaOCL Sodium Hypochlorite
• Version Model Number: 317018
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207020397 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-19
• Device Publish Date: 2018-08-06

On-Brand Devices [3% NaOCL Sodium Hypochlorite]

• 10818207020427: For the debridement and irrigation of root canals during and after instrumentation. 12ml kit.
• 10818207020410: For the debridement and irrigation of root canals during and after instrumentation. 3ml kit.
• 10818207020403: For the debridement and irrigation of root canals during and after instrumentation. 32 ounce bo
• 10818207020397: For the debridement and irrigation of root canals during and after instrumentation. 16 ounce bot