Nakanishi, Inc. · Class II · Cleared Sep 19, 2025
| K-number | K251689 |
| Device name | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) |
| Applicant | Nakanishi, Inc. |
| Product code | ELC |
| Device class | Class II |
| Decision date | Sep 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.4850 |
The VARIOS 170 LUX SCALER SYSTEM is an electronic ultrasonic dental scaler that converts electrical signals into mechanical vibrations via piezoelectric ceramics to vibrate tips at ultrasonic frequencies. It is intended for scaling, periodontal treatment, implant maintenance, endodontics, restorative work, and prosthodontic applications in dental practice.
The subject control unit is designed to be embedded into a dental delivery system, a feature not present in the predicate device but included in a reference device. The ultrasonic handpiece has the same functionality as the predicate but uses different material in biological contact with tissue.
ISO 18397:2016 (powered scaler), ISO 17665-1:2006 and ISO 17664-1:2021 & 17664-2:2021 (sterilization and reprocessing), IEC 62304:2006+AMD1:2015 (software life cycle), IEC 60601-1:2005+AMD1:2012+AMD2:2020 and IEC 60601-1-2:2014+AMD1:2020 (electrical safety and EMC), IEC 81001-5-1:2021 (cybersecurity), ISO 10993-1:2018 (biocompatibility).
Both devices share the same indications for use in dental scaling and endodontics. The subject device's handpiece performs identically to the predicate despite material differences in biological contact, and biocompatibility testing confirms safety for limited-contact use. Performance testing demonstrates compliance with the same relevant standards, supporting functional and safety equivalence to the predicate device.
View the full FDA submission: accessdata.fda.gov