FDA Product Code
FDA Product Code EBW — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4200
510(k) Clearances — 62 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260027 | Firstar Dental Electric Motor | FDC Technology Industry Co. | 2026-10-01 | Traditional | PDF ↗ |
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | 2026-01-30 | Traditional | PDF ↗ |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026-01-12 | Traditional | PDF ↗ |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025-08-25 | Traditional | PDF ↗ |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | 2025-07-18 | Special | PDF ↗ |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | 2025-04-11 | Traditional | PDF ↗ |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024-06-24 | Traditional | PDF ↗ |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | 2024-06-20 | Traditional | PDF ↗ |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. | 2024-04-01 | Traditional | PDF ↗ |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | 2024-03-11 | Traditional | PDF ↗ |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2022-09-27 | Traditional | PDF ↗ |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | Cefla S.C. | 2022-05-09 | Traditional | PDF ↗ |
| K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2022-03-11 | Traditional | PDF ↗ |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | 2022-02-07 | Traditional | PDF ↗ |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-01-13 | Traditional | PDF ↗ |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | 2021-05-21 | Traditional | PDF ↗ |
| K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | 2021-02-11 | Traditional | PDF ↗ |
| K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | 2020-09-04 | Traditional | PDF ↗ |
| K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | 2019-07-25 | Traditional | PDF ↗ |
| K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019-03-26 | Traditional | PDF ↗ |
| K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | 2018-06-19 | Traditional | PDF ↗ |
| K163402 | NLZ Motor System | Nakanishi, Inc. | 2017-08-31 | Traditional | PDF ↗ |
| K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017-05-11 | Traditional | PDF ↗ |
| K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | 2017-02-21 | Traditional | PDF ↗ |
| K161213 | XSmart iQ | Dentsply Sirona | 2017-02-10 | Traditional | PDF ↗ |
| K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016-11-23 | Traditional | PDF ↗ |
| K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015-04-24 | Traditional | PDF ↗ |
| K140308 | MASTERSURG / EXPERTSURG | Kaltenbach & Voigt GmbH | 2014-08-15 | Traditional | PDF ↗ |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | A-Dec, Inc. | 2014-05-28 | Special | PDF ↗ |
| K132570 | ELECTRIC HANDPIECE SYSTEM | Ttbio Corp. | 2014-04-29 | Abbreviated | PDF ↗ |
| K123608 | ENDO E CLASS | Saeyang Microtech Co., Ltd. | 2013-08-16 | Traditional | PDF ↗ |
| K111623 | I-ENDO DUAL | Satelec - Acteon Group | 2012-01-10 | Traditional | PDF ↗ |
| K103027 | ELECTROTORQUE TLC | Kaltenbach & Voigt GmbH | 2011-08-19 | Traditional | PDF ↗ |
| K103653 | E3 TORQUE CONTROL MOTOR | Dentsply International, Inc. | 2011-05-26 | Traditional | PDF ↗ |
| K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT | Anthogyr Sas | 2011-03-23 | Traditional | PDF ↗ |
| K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | Bonart Co., Ltd. | 2010-12-03 | Traditional | PDF ↗ |
| K092214 | CHIROPRO L SYSTEM | Bien-Air Dental, SA | 2009-12-15 | Traditional | PDF ↗ |
| K092758 | X-CUBE | Saeshin Precision Co., Ltd. | 2009-09-21 | Traditional | PDF ↗ |
| K090727 | IMM DENTAL IRRIGATION TUBING SET | Innovative Medical Manufacturing Co. | 2009-08-13 | Traditional | PDF ↗ |
| K090937 | E-STATIS 40 SYSTEM | Scican , Ltd. | 2009-07-24 | Traditional | PDF ↗ |
| K083252 | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM | Dentalez Group, Stardental Division | 2009-02-18 | Traditional | PDF ↗ |
| K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH | 2006-05-03 | Traditional | PDF ↗ |
| K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | W&H Dentalwerk Buermoos GmbH | 2006-01-13 | Traditional | PDF ↗ |
| K041124 | IRRIGATION TUBING SET 2.2M AND 3.8M | W&H Dentalwerk Burmoos | 2004-06-07 | Traditional | PDF ↗ |
| K040153 | I-TEC PORTABLE DENTAL OPERATORY | Indigenous Peoples Technology and Education Center | 2004-05-21 | Traditional | PDF ↗ |
| K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | A-Dec, Inc. | 2003-12-03 | Traditional | PDF ↗ |
| K031584 | SIROTORQUE L | Sirona Dental Systems GmbH | 2003-08-19 | Traditional | PDF ↗ |
| K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | W&H Dentalwerk Buermoos GmbH | 2002-05-03 | Traditional | PDF ↗ |
| K020327 | SURGIC IV IMPLANT CONTROL UNIT | Nakanishi, Inc. | 2002-04-08 | Traditional | PDF ↗ |
| K011926 | ELEC-MATE E | Nakanishi, Inc. | 2001-09-11 | Traditional | PDF ↗ |
| K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001-02-07 | Traditional | PDF ↗ |
| K000120 | PRO-TORQ | Micro Motors, Inc. | 2000-02-03 | Special | PDF ↗ |
| K992648 | ROTARY MASTER | J. Morita USA, Inc. | 2000-01-31 | Traditional | PDF ↗ |
| K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | Nsk Nakanishi, Inc. | 1999-06-09 | Traditional | PDF ↗ |
| K972889 | ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) | W & H Dentalwerk | 1998-01-22 | Traditional | PDF ↗ |
| K972924 | SURGIC II IMPLANT CONTROL UNIT | Nsk Nakanishi, Inc. | 1997-10-30 | Traditional | PDF ↗ |
| K964860 | MARK 20 AND MARK 25 HAND ENGINE CONTROLLER | Bell Intl., Inc. | 1997-03-03 | Traditional | PDF ↗ |
| K964863 | MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN | Bell Intl., Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH | Site Microsurgical Systems, Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K790322 | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 | Applied Medical Research | 1979-05-14 | Traditional | PDF ↗ |
| K770129 | SPRINT S-2 INSTRU. CENTER (MODEL 92329) | Chemetron Health Systems | 1977-01-28 | Traditional | PDF ↗ |
Product code EBW · Class I · Dental. Data: openFDA.