VARIOSURG— 510(k) K073678

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K073678 for VARIOSURG, Substantially Equivalent on 2008-07-10. Applicant: Nakanishi, Inc.. Device class: 2.

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code DZI
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2007-12-28
Decision date: 2008-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZI

K253655 — Angled Screwdriver MED (M-SD090)2026-07-31
K253776 — Implantmed Plus II & Piezomed Plus II Module2026-06-18
K254163 — VarioSurg 42025-12-23
K242432 — MT-Bone2024-08-19
K240340 — Surgical Drive System (Model: ES70, ES90, E8)2024-07-18

More clearances from Nakanishi, Inc.

K260773 — Varios Combi Pro22026-03-10
K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more2025-09-19
K252662 — UniBur2025-09-19
K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)2024-09-20
K233288 — NLZ Built-In Motor System2024-06-24

Recalls naming K073678

K-number listed on FDA's recall record

Z-2673-2016 — Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.Class II·Terminated·Nakanishi Inc.·20160708

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073678.

Data sourced from openFDA. This site is unofficial and independent of the FDA.