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VELOCITY WATER®

Anodia Systems · Model (01)00854542008341 · UDI-DI 00854542008341

EIA

510(k) clearances

1,407

Adverse events

Recalls

111

Facilities

Description

VELOCITY WATER® is used for dental units on city water in which the dental lines are to be cleaned (Manufacturer # MAK-1805). Designed with toggle switches allowing the dental personnel to have complete control of the cleaning. One toggle switch controls the incoming water to the dental unit in reference to being on or off. The other toggle switch allows the dental personnel to air purge the waterlines and then inject a liquid cleaner into the waterlines.

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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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.