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Quolis 5000 Series Dental Unit
TAKARA BELMONT CORP. · Model AU-BDS5180 · UDI-DI 04952195089413
EIA
Prescription
1
510(k) clearances
1,407
Adverse events
4
Recalls
111
Facilities
Description
BELMONT QUOLIS 5000 SERIES DENTAL UNIT CUSPIDOR WITHOUT ASSISTANT INSTRUMENTS
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-06-24 | Danville Materials, Inc. | The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data |
| 2014-04-23 | William C. Domb, D.M.D., A Professional Corporation | William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use. |
| 2013-11-05 | ASI Medical, Inc. | ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture. |
| 2012-02-20 | Pelton & Crane Company | Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating |
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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.