VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more— 510(k) K251689
Substantially EquivalentNakanishi, Inc.
FDA 510(k) clearance K251689 for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more, Substantially Equivalent on 2025-09-19. Applicant: Nakanishi, Inc.. Device class: 2.
Clearance details
- Device name as filed
- VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
- Applicant
- Nakanishi, Inc.
- Product code
- Code ELC
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kanuma, JP
Recent devices under product code ELC
view all- K260773 — Varios Combi Pro2
- K253254 — GBT Machine Airflow Prophylaxis Master
- K242317 — Integrated Endo System (Meet Endo-II)
- K233844 — OdneClean
- K240707 — Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
More clearances from Nakanishi, Inc.
view allAdverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.