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APOZA
APOZA ENTERPRISE CO., LTD. · Model PROPHY APII · UDI-DI 04719883751102
ELC
Prescription
1
510(k) clearances
3,281
Adverse events (3 deaths)
10
Recalls
107
Facilities
Description
PROPHY APII is designed to clean extrinsic stains caused by tobacco, tea, coffee or food on tooth surfaces by using sodium bicarbonate. The air and water are supplied from dental unit.
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.