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510(k) K252662

UniBur by Nakanishi, Inc. — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
August 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

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  • 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)
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  • K222518 — FX Contra (November 17, 2022)

Other clearances for product code HBE

  • K250815 — Hubly Drill (H100) (November 6, 2025)
  • K252060 — GREEN (October 31, 2025)
  • K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070 (June 4, 2025)
  • K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0 (March 13, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K232684 — Surgify Halo (November 29, 2023)
  • K230619 — Hubly Electric Drill (H100) (May 4, 2023)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K213072 — 2.1 x 255mm Drill, 22mm Stop (August 23, 2022)
  • K213208 — Twist Drills (December 23, 2021)