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OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS

Osstem Implant Co.,Ltd. · Model K3-Chair only · UDI-DI 08800000995724

NRU Prescription
0
510(k) clearances
33
Adverse events
4
Recalls
109
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

DateFirmReason
2011-03-04Pelton & Crane CompanyThe Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.
2011-03-04Pelton & Crane CompanyThe Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.
2011-03-01Dental Equipment LLCLink arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
2010-03-23Dental Equipment LLCThe magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond

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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.