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OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

Osstem Implant Co.,Ltd. · Model K3 · UDI-DI 08800000995045

EIA Prescription

510(k) clearances

1,407

Adverse events

Recalls

111

Facilities

Description

A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor and occasionally the operating light. The patient examination/treatment chair is often connected to this unit.

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.