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.
Laser, Dental, Soft Tissue
General, Plastic Surgery
The Dental Soft Tissue Laser is a surgical laser device intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. It enables precise, minimally invasive soft tissue procedures in the oral cavity with reduced bleeding compared to conventional surgical instruments. It is an FDA Class 2 device regulated under 21 CFR 878.4810 in the General and Plastic Surgery specialty, reviewed by the Dental panel, with product code NVK, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
510(k) Clearances
17 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.