Home › Device types › ELC
Scaler, Ultrasonic
FDA product code ELC · Class 2 · Dental
3,739
Registered devices
3,281
Adverse events
10
Recalls
195
510(k) clearances
Devices with this code
MECTRON — MECTRON SPAACTEON — SATELECSONICflex paro Tip No. 61 (A) — KaVo Dental GmbHPIEZON — E.M.S. Electro Medical Systems S.A.Cavitron® — Dentsply ProfessionalPIEZON — E.M.S. Electro Medical Systems S.A.Cavitron® — Dentsply ProfessionalMECTRON — MECTRON SPAACTEON — SATELECWOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.P4 TRANSFORMER -115V — BONART CO., LTD.MECTRON — MECTRON SPADTE — Guilin Woodpecker Medical Instrument Co., Ltd.DTE — Guilin Woodpecker Medical Instrument Co., Ltd.Advanced Endodontic System — ASI MEDICAL, INC.DBA — Guilin Woodpecker Medical Instrument Co., Ltd.socket lift kit for wide size implant — NAKANISHI INC.MECTRON — MECTRON SPAMECTRON — MECTRON SPADarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCMECTRON — MECTRON SPAWOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.AS2000 M4 — NAKANISHI INC.ST86 — OSADA ELECTRIC CO.,LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-30 | Dental EZ Group Star Dental Division | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury |
| 2024-05-30 | Dental EZ Group Star Dental Division | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury |
| 2024-03-13 | Electro Medical Systems SA | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or stora |
| 2024-03-13 | Electro Medical Systems SA | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or stora |
| 2024-03-13 | Electro Medical Systems SA | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or stora |
| 2022-10-14 | Sonendo Inc | Procedure Instruments with erroneous unit carton labels. |
| 2022-10-14 | Sonendo Inc | Procedure Instruments with erroneous unit carton labels. |
| 2019-10-23 | Sonendo Inc | The console would continue to run for extended period when the foot pedal was released. |
| 2016-07-08 | Nakanishi Inc. | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor t |
| 2016-07-08 | Nakanishi Inc. | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor t |
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