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AIR-FLOW
E.M.S. Electro Medical Systems S.A. · Model a · UDI-DI 07613353046743
EFB
Prescription
1
510(k) clearances
2,071
Adverse events
8
Recalls
97
Facilities
Description
handy 3.0 basic - Sirona
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-01-20 | Coltene Whaledent Inc | Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines hea |
| 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 |
| 2012-05-07 | MTI Precision Products LLC. | Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. |
| 2006-11-22 | Kavo America Corporation | The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| 2003-10-14 | DentSply -Professional Division | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
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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.