Home / 510(k) Clearances / K171155

510(k) K171155

Surgical Angle Handpiece, Surgical Straight Handpiece by Nakanishi, Inc. — Product Code KMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2017
Date Received
April 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Rotary Bone Cutting
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Nakanishi, Inc.

  • K260773 — Varios Combi Pro2 (March 10, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K252662 — UniBur (September 19, 2025)
  • K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170L (September 19, 2025)
  • K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing Sys (September 20, 2024)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (April 25, 2024)
  • K230888 — Titanium Turbine (June 2, 2023)
  • K230106 — General Cutting Straight (May 24, 2023)

Other clearances for product code KMW

  • K211584 — Oral Surgery Contra (August 19, 2021)
  • K162544 — OsteoMed PINNACLE Driver (April 4, 2017)
  • K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (July 29, 2008)
  • K994298 — FRIOS MICROSAW (February 18, 2000)
  • K971692 — OSTEOPOWER SYSTEM AND ACCESSORIES (June 27, 1997)
  • K970953 — E-TYPE SPEED REDUCER CONTRA ANGLE (April 15, 1997)
  • K932255 — YOUNG D'GRANULATOR (April 15, 1994)
  • K862110 — OSSEODENT DRILLING SYSTEM (August 7, 1986)