Cleared Traditional

K073678 - VARIOSURG

K073678 is an FDA 510(k) clearance for VARIOSURG, manufactured by Nakanishi, Inc.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K073678 · Nakanishi, Inc. · Dental device
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Jul 2008
Decision
195d
Days
Class 2
Risk

K073678 is an FDA 510(k) clearance for the VARIOSURG. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Washington, US). The FDA issued a Cleared decision on July 10, 2008 after a review of 195 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K073678

510(k) Number K073678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2007
Decision Date July 10, 2008
Days to Decision 195 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 128d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZI Drill, Bone, Powered

All 49
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K073678.
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K072146 · E.M.S Electro Medical Systems S.A · Dec 2007
IMPLANT CENTER
K072030 · Satelec - Acteon Group · Nov 2007
PIEZOTOME
K060274 · Satelec · May 2006
K073678 · VARIOSURG
Download PDF Nakanishi, Inc.