Home › Device types › ELC
Scaler, Ultrasonic
FDA product code ELC · Class 2 · Dental
3,779
Registered devices
3,287
Adverse events
10
Recalls
195
510(k) clearances
Devices with this code
AIR-FLOW — E.M.S. Electro Medical Systems S.A.DTE,WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.ACTEON — SATELECProUltra PiezoFlow — TULSA DENTAL PRODUCTS LLCVarios — NAKANISHI INC.BioSonic — COLTENE/WHALEDENT INCObtura Spartan — OBTURA SPARTAN ENDODONTICSCAD-CAM mesial gebogen No. 34 — KaVo Dental GmbHSIROPERIO — SIRONA Dental Systems GmbHTUN Ultrasonic Tip — Engineered Endodontics, LLCBaolai — Nanning Baolai medical instrument Co.,LtdWOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd.Clean Machine™ — PARKELL, INC.Piezon — E.M.S. Electro Medical Systems S.A.Ultrasonic Tips — Kerr CorporationACTEON — SATELECACTEON — SATELECBioSonic — COLTENE/WHALEDENT INCAIR-FLOW-PIEZON — E.M.S. Electro Medical Systems S.A.Instrument S5 — W & H Dentalwerk Bürmoos GmbHBioSonic — Dent4You AGPro-Select Platinum® — DEN-MAT HOLDINGS, LLCSONICflex retro Tip No. 56 — KaVo Dental GmbHMECTRON — MECTRON SPA
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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