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CEFLA SOCIETA' COOPERATIVA · Model C-U2 · UDI-DI 08033837930174
EIA
Prescription
1
510(k) clearances
1,407
Adverse events
4
Recalls
111
Facilities
Description
The device is a camera system specifically intended to examine the oral cavity. This system is designed to allow the dentist to more efficiently show and explain to patients all oral conditions and reasons for planned treatment.
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.