(569 days)
K3 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
K3, Dental Unit and Chair, is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with ISO 7494-1, ISO 7494-2 and ISO 6875. The 3way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.
This FDA 510(k) summary describes the K3 dental unit, which is a dental operative unit and accessories, including a dental chair. The submission aims to establish substantial equivalence to a predicate device, the Sirona C8 (K983242).
Here's the breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet for a particular clinical task. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended use. The "reported device performance" is largely framed within compliance with various international standards and the comparison table.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| 1. Intended Use Equivalence | K3 is intended to supply power to and serve as a base for dental devices and accessories, including a dental chair, for use in a dental clinic by trained dentists and/or dental assistants. This is compared directly to the predicate device's intended use. |
| 2. Technical Characteristics Equivalence | Power and Utility Supply: AC 100-120/220-240V, 50/60Hz, compressed air and water (Predicate: 110V/220V AC, compressed air and water). |
| Protection Class: Class 1 equipment (Same as predicate). | |
| Applied parts: Type B (Same as predicate). | |
| Air Pressure: 500kPa(min)/750kPa(max) (Predicate: 550 kPa/750 kPa). | |
| Water Pressure: 250kPa(min)/600 kPa(max) (Same as predicate). | |
| Water System: City water supply (Predicate: User may select self-contained or city water supply). | |
| Patient load: Max. 135kg (Same as predicate). | |
| Chair Height: Max. 790±10mm, Min. 450±10mm (Predicate: Max.755mm, Min. 395mm). | |
| Back Rest: 0° to 66° (Predicate: 0° to 60°). | |
| Head Rest: -10° to 45° (Same as predicate). | |
| 3. Electrical Safety Compliance | Complies with IEC 60601-1 (Same as predicate). |
| 4. EMC Compliance | Complies with IEC 60601-1-2, EN55011, EN 61000-3-2, EN 61000-3-3 (Same as predicate on IEC 60601-1-2). |
| 5. Biocompatibility (for contacting components) | Components (upholstery, waterlines, airlines) tested for cytotoxicity (ISO 10993-5) and found acceptable. Considered external communicating device for |
§ 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.