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Molar Procedure Instrument with Accessories
SONENDO, INC. · Model FG-001-00023 · UDI-DI 00858395006325
ELC
Prescription
10
510(k) clearances
3,283
Adverse events (3 deaths)
10
Recalls
107
Facilities
Description
The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
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 storage if the use is not |
| 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 storage if the use is not |
| 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 storage if the use is not |
| 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 to this error is that |
| 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 to this error is that |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.