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Midmark

MIDMARK CORPORATION · Model 153603LR · UDI-DI 00841709110320

EIA Prescription
1
510(k) clearances
1,407
Adverse events
4
Recalls
111
Facilities

Description

The Procenter Concept LR Mounted Cuspidor is intended to provide water for oral rinsing, and a drain to dispose of waste water and oral debris during dental examinations.

Recalls

DateFirmReason
2016-06-24Danville 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
2014-04-23William C. Domb, D.M.D., A Professional CorporationWilliam Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
2013-11-05ASI Medical, Inc.ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
2012-02-20Pelton & Crane CompanyModification 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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Data 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.