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OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
Osstem Implant Co.,Ltd. · Model K5 · UDI-DI 08800000996264
1
510(k) clearances
1,407
Adverse events
4
Recalls
111
Facilities
Description
The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments.
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.