FDA-Device2018-10-31Class II
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
Nakanishi Inc.
Hazard
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Sold states
U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Affected count
12
Manufactured in
700, Shimohinata, Kanuma, N/A, Japan
Products
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0219-2019Don't want to check this manually?
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