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U.S. Department of Health and Human Services

Product Classification

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Device handpiece, air-powered, root canal irrigation
Definition To clean the root canal prior to filling and used for root canal irrigation.
Physical State It is composed or aluminum, stainless steel and plastic
Technical Method It is attached to the coupling for the dental handpiece and is used to provide irrigation solution into the root canal
Target Area It is used to treat a tooth during a root canal procedure
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNYL
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4200
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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