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510(k) Data Aggregation
K Number
K202906Device Name
EndoPilot2
Manufacturer
Schlumbohm GmbH & Co. KG
Date Cleared
2021-04-13
(196 days)
Product Code
ELC, EKR, EKX, LQY
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
**Schlumbohm GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.
The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.
Device Description
The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.
These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.
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