# K171155: Surgical Angle Handpiece, Surgical Straight Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Nov 21, 2017 after 215 days
- Product code: KMW (Handpiece, Rotary Bone Cutting)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971350 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111532: Montblanc Surgical Contra-Angle and Straight Handpiece, Anthogyr Sas (2011) Summary page 4.
- K970953: E-Type Speed Reducer Contra Angle, Nsk Nakanishi, Inc. (1997) Summary page 4.

## Recalls of this device
- Jun 1, 2018 · Class II · Z-0220-2019: 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 manual
- Jun 1, 2018 · Class II · Z-0222-2019: 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
- Jun 1, 2018 · Class II · Z-0225-2019: 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
- Jun 1, 2018 · Class II · Z-0224-2019: 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
- Jun 1, 2018 · Class II · Z-0219-2019: 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 manual
- Jun 1, 2018 · Class II · Z-0221-2019: 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 manual
- Jun 1, 2018 · Class II · Z-0223-2019: 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
- Jun 1, 2018 · Class II · Z-0226-2019: 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

## Indications for use
The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, cutting teeth, oral surgery (such as root tip resection, bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).

Source page: https://510kreport.com/device/K171155
Methodology: https://510kreport.com/methodology