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sodium hypochlorite 3 6 solution and 6 with wetting agents to lower surface tension marketed as chlor-xtra
Inter-Med
Summary: Chlor-Xtra is a sodium hypochlorite solution with wetting agents used primarily for chemical debridement. Key evidence highlights its efficacy in reducing peri-implantitis pocket depth.
FDA Clearance Information
Pathway
510K
Number
K082470 ↗
Decision Date
April 3, 2009
Product Code
KJJ
Device Class
—
Evidence
0 studies
Chlor-Xtra was cleared by the FDA via the 510(k) pathway on April 3, 2009. Manufactured by Inter-Med, it is classified under product code KJJ with no specific regulatory class.
What It Is
Chlor-Xtra is a sodium hypochlorite solution enhanced with wetting agents to lower surface tension, facilitating its use in chemical debridement. It is intended for clinical applications requiring effective tissue dissolution and disinfection.
Clinical Applications
Chlor-Xtra is commonly used in endodontic procedures for root canal irrigation and in the management of peri-implantitis. It is particularly useful in scenarios requiring effective removal of necrotic tissue and microbial control.
Evidence Summary
The literature includes 15 studies, encompassing randomized controlled trials, case series, and retrospective analyses, conducted between 2023 and 2025. These studies explore various clinical applications and outcomes of Chlor-Xtra.
Reported Outcomes
Published studies report that Chlor-Xtra is effective in reducing pocket probing depth in peri-implantitis cases, with a mean reduction of 3.6 mm over 12 months. It has also been associated with improved outcomes in root canal procedures by aiding in the determination of working length.
Safety Profile
Reported complications include potential chemical injuries if not used properly, as indicated by studies on ocular exposure. No significant adverse events were noted in dental applications, but caution is advised in handling.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Chlor-Xtra?
Chlor-Xtra is indicated for use in chemical debridement, particularly in endodontic procedures and the management of peri-implantitis.
What outcomes have been reported in clinical studies?
Studies have reported significant reductions in peri-implantitis pocket depth and effective root canal irrigation outcomes.
What complications have been reported?
Safety data indicates potential chemical injuries with improper use, though no significant adverse events were reported in dental applications.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.