FDA-Device2018-10-31Class II

Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: 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
1662
Manufactured in
700, Shimohinata, Kanuma, N/A, Japan
Products
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: 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-0224-2019

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