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SDIF Dental chairs with operative unit is indicated for use to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is indicated for use in the dental clinic/office environment used by trained dentists and/or dental technicians and assistants

SDIF dental chairs with operative units provide patient comfort and dentists' air and water supplies for dental instruments and procedures. Water pressure: 200~400Kpa. Air water Supplios for dontar mounts can be powered from ~110/220/230V. The chair is protoure. The system is compatible with instruments from various manufacturers with standard fittings.

The provided text is a 510(k) summary for a "SDIF Dental chair with Operative Unit and accessories". It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

Specifically, the document states:

• "14-Safety and Effectiveness of the device: This device is safe and effective as the other predicate device cited above." This is a claim of substantial equivalence based on the predicate, not a report of a specific study to meet acceptance criteria.
• The FDA letter (pages 1-3) confirms the substantial equivalence determination based on the information provided in the 510(k) submission but does not detail the specific performance studies that show the device meets acceptance criteria.

Therefore, I cannot provide the requested table and study details as the information is not present in the provided document. The document is primarily focused on describing the device and its intended use for regulatory clearance, not on detailing a performance study with specific acceptance criteria.

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