SM3
Osstem Implant Co., Ltd._Gasan Branch · Model SM3 120V OPT · UDI-DI 08800000995212
9
510(k) clearances
309
Adverse events (1 deaths)
10
Recalls
17
Facilities
Description
SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-16 | W&H DENTALWERK BUERMOOS GMBH | 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of t |
| 2021-10-28 | Osteomed, LLC | Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev |
| 2018-06-01 | Nakanishi Inc. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev |
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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.