510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Dental Barriers And Sleeves
General, Plastic Surgery
The Dental Barriers and Sleeves are disposable covers intended to serve as barriers for dental instruments and equipment surfaces to reduce the risk of cross-contamination between dental patients. They fall under the General and Plastic Surgery medical specialty (per the regulation classification) and are classified as a Class 2 device under regulation 878.4370, requiring 510(k) premarket notification. These single-use barriers are a fundamental infection control measure in dental practice. They are not implants and are not life-sustaining.
510(k) Clearances
15 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.