510(k) K260773
- Device
- Varios Combi Pro2
- Applicant
- Nakanishi, Inc.
- 510(k) number
- K260773
- Product code
- ELC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-10
- Date received
- 2026-03-09
- Regulation
- 872.4850
- Classification name
- Scaler, Ultrasonic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Related Records
Applicant Contact
- Contact
- Kikuchi Masaaki
- Address
- 700 Shimohinata Kanuma JP 322-8666 322-8666
FDA Registration Numbers
- 3008912871
- 3003934980
- 1032227
- 1054713
- 3008770655
- 3004569445
- 3013022399
- 3004884150
- 3003933619
- 3008615394
- 9710363
- 3008910197
- 3012187973
- 8044015
- 9681479
- 1718912
- 9614726
- 1941138
- 3030405669
- 3000219976
- 2127132
- 3010373292
- 9616762
- 3022516928
- 9614977
- 3004193466
- 3013298431
- 2031508
- 3010864832
- 1419489
- 2024980
- 3009968482
- 3015729
- 3012477813
- 3010817521
- 2521453
- 3012421607
- 3016075921
- 2511556
- 2020943
- 3005282635
- 2320721
- 2424472
- 3012322979
- 1722638
- 3003637274
- 3006750855
- 8032033
- 9611253
- 3008590661
- 3005972890
- 3012494290
- 3010364969
- 2024312
- 3027615
- 3012354669
- 2832
- 8044167
- 2416455
- 2411797
- 1422375
- 8043962
- 3018783058
- 3014683120
- 2183301
- 3038718579
- 3008559238
- 3017618678
- 3011944170
- 3006610845
- 3007962015
- 3004096429
- 3014315145
- 3005581016
- 3030126955
- 1413475
- 1416605
- 3016114530
- 2520265
- 3018975080
- 2018957
- 3038220293
- 2024949
- 3043226252
- 8030987
- 8010468
- 3033858988
- 3003120666
- 3007279848
- 3023861999
- 3029780
- 3014953747
- 3017604
- 3005344591
- 2243757
- 1648564
- 3042256012
- 2433629
- 1052939
- 3012711663
- 3011300255
- 9680864
Source Documents
Other 510(k) Records For Product Code ELC
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|---|---|---|---|
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | 2026-01-28 |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | 2025-09-19 |
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| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | 2023-12-11 |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-21 |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | 2023-07-14 |
| K231391 | Combi Touch | Mectron S.P.A. | 2023-05-15 |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | 2023-03-23 |
| K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | Changzhou Bomedent Medical Technology Co.,Ltd | 2022-09-08 |
| K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | 2022-02-02 |
| K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-10 |