(73 days)
Planmeca Sovereign is a dental operative unit, which is an ACpowered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device includes a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.
The Planmeca Sovereign is a dental operative unit including a dental patient chair. The design is very flexible with many motorized functions, and both left-handed and righthanded use is easily obtainable. The dentist and assistant are allowed to change their working postures according to the operation to be performed. The versatile swivelling enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use. The instrument console includes six instrument locations, with easy instrument interchange.
The provided document, K081699 for the Planmeca Sovereign, outlines the product description, intended use, and its classification by the FDA. However, it does not contain information regarding acceptance criteria, performance studies, or clinical trial data typically associated with AI-powered devices or diagnostic tools.
The Planmeca Sovereign is described as a "dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories" and includes a "dental patient chair, which is intended to properly position a patient to perform different dental procedures."
This type of device (a dental operative unit and patient chair) is a Class I medical device (Regulation Number: 21 CFR 872.6640, Product Code: EIA), which typically has a lower regulatory burden than Class II or III devices and often relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies.
Therefore, I cannot provide the requested information about acceptance criteria, performance data, or study details because the document does not discuss these aspects for the Planmeca Sovereign. The approval is based on its classification and substantial equivalence to existing devices, not on a performance study against specific acceptance criteria like an AI-powered diagnostic tool would require.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.