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510(k) K031421

Device
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
Applicant
NAKANISHI, INC.
510(k) number
K031421
Product code
ELC  
Decision
Substantially Equivalent (SESE)
Decision date
2004-03-26
Date received
2003-05-05
Regulation
872.4850
Classification name
Scaler, Ultrasonic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MASAYUKI ONOGUCHI
Address
700b Cooper Ct. Schaumburg IL US 60173 60173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260773Varios Combi Pro2Nakanishi, Inc.2026-03-10
K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A2026-01-28
K251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.2025-09-19
K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.2025-02-13
K233844OdneCleanOdne AG2024-08-08
K240707Ultrasonic 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)Shenzhen Micro Electric Intelligence Co., Ltd.2024-07-02
K240801BioSonic US200 Ultrasonic Scaler (60034537)Dent4you AG2024-07-01
K233922SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONGSatelec - Acteon Group2024-03-11
K223340EDS Calculus Softener TURBO CREssential Dental Systems, Inc.2023-12-11
K230641Ultrasonic Scaler TipsGuilin Refine Medical Instrument Co., Ltd.2023-11-21
K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH2023-07-14
K231391Combi TouchMectron S.P.A.2023-05-15
K222096Endo Ultrasonic ActivatorFoshan Coxo Medical Instrument Co., Ltd.2023-03-23
K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd2022-09-08
K210832EVOCLEAN CLEANsert Ultrasonic InsertTtbio Corp.2022-02-02

Legacy Summary#

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FDA Review#

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