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The SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The SUPERtorque High-Speed Handpieces are dental handpieces for use by a trained professional in general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices can be sterilized by the steam autoclave method.

The GENTLEpower Handpieces and Attachments are dental instruments for use by a trained professional in general dentistry. The handpieces and attachments are powered by either an air-motor or electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The provided text is a 510(k) Summary for dental handpieces. It describes the devices, their intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The document discusses:

• Device Names: SUPERtorque High-Speed Handpieces and GENTLEpower Handpieces and Attachments
• Common Name: Dental Handpiece
• Classification Name: Handpiece, Air-Powered, Dental
• Intended Use: Removal of carious material, reducing hard tooth structure, cavity/crown preparation, finishing tooth preparations, restorations, and polishing teeth.
• Predicate Devices: Siemens AG (now Sirona) T1 Control High-Speed Dental Handpieces (K965238), DEN-TAL-EZ, Inc. STAR DENTAL 430 Series High-Speed Handpieces (K960719), and A-DEC/W&H Synea Air-Driven Highspeed Handpieces and Attachments (K070663).
• Regulatory information: Product codes, regulation number, and classification.

To answer your request, a document detailing performance testing, clinical studies, or engineering studies would be required. The given text is purely for regulatory submission and substantial equivalence claims, not for scientific performance validation.

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