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510(k) K241880

Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) by Nakanishi, Inc. — Product Code EFB

K241880 is an FDA 510(k) premarket notification submitted by Nakanishi, Inc. for the device "Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)". The FDA issued a decision of Substantially Equivalent on September 20, 2024. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Nakanishi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
June 28, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Nakanishi, Inc.

  • K260773 — Varios Combi Pro2 (March 10, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170L (September 19, 2025)
  • K252662 — UniBur (September 19, 2025)
  • 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)
  • K222518 — FX Contra (November 17, 2022)

Other clearances for product code EFB

  • K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES (January 12, 2026)
  • K251389 — High speed air turbine handpiece (January 12, 2026)
  • K242179 — Synea Fusion Handpieces (Intensiv & Profin) (February 28, 2025)
  • K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, (November 13, 2024)
  • K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dent (November 12, 2024)
  • K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L, (April 30, 2024)
  • K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (April 25, 2024)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K232243 — EVO 700 series high speed handpiece (August 23, 2023)
  • K230888 — Titanium Turbine (June 2, 2023)

FDA data resources