(420 days)
Intended to help prevent gross contamination of the dental operatory unit.
Not Found
This document is a 510(k) clearance letter for the IGN 500 Waterline Unit. It indicates that the device has been found substantially equivalent to a predicate device marketed before May 28, 1976. This type of document does not contain acceptance criteria for device performance or any studies demonstrating that the device meets such criteria.
The core purpose of a 510(k) submission and the resulting clearance letter is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to provide detailed performance data and acceptance criteria in the format you requested.
Therefore, I cannot extract the requested information from the provided text. The document states:
- Trade Name: IGN 500 Waterline Unit
- Regulatory Class: I
- Product Code: EIA (which typically refers to a water purification, unit, dental)
- Indications For Use: Intended to help prevent gross contamination of the dental operatory unit.
To answer your questions, one would need access to the actual 510(k) submission document (K964271), specifically the sections pertaining to performance testing, if any were submitted beyond basic safety and substantial equivalence comparisons. For Class I devices, extensive clinical studies or detailed performance trials with specific acceptance criteria are often not a prerequisite for 510(k) clearance, as the focus is on demonstrating equivalence to an existing device rather than proving novel clinical effectiveness.
§ 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.