Chlor-XTRA

GUDID 10818207020489

Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation, debridement and cleansing of root canals during and after instrumentation. 32 ounce bottle.

Vista Dental

Antimicrobial wound irrigation solution, non-sterile

• Primary Device ID: 10818207020489
• NIH Device Record Key: f4cf3ed5-4887-46f0-bd23-c97eb04fb2ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chlor-XTRA
• Version Model Number: 281410
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 2
• 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	00818207020482 [Unit of Use]
GS1	10818207020489 [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 [Chlor-XTRA]

• 10818207020502: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
• 10818207020496: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
• 10818207020489: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,
• 10818207020472: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation,