Cleared Traditional

K203791 - Stainless Turbine

K203791 is the FDA 510(k) clearance for Stainless Turbine by Nakanishi, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 540-day FDA review.

K203791 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
540d
Days
Class 1
Risk

K203791 is an FDA 510(k) clearance for the Stainless Turbine. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on June 21, 2022 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Nakanishi, Inc. devices

Submission Details

510(k) Number K203791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2020
Decision Date June 21, 2022
Days to Decision 540 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
413d slower than avg
Panel avg: 127d · This submission: 540d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Ken Block Consulting, LLC
Kelby Villarreal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 77
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K203791.
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
K212910 · Shenzhen Carejoy Technology Co., Ltd. · Nov 2022
Dental Air Polishing Handpiece
K221548 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2022
OK Handpiece
K221814 · Jaintek Co.,Ltd · Jul 2022
Highspeed Airturbine Handpiece
K202371 · Beijing Dongbo Dental Handpiece Co., Ltd. · Nov 2021
Dental Low-speed Handpieces and Accessories
K202786 · Microp Technology (Taiwan), Inc. · Sep 2021
Disposable High Speed Air Turbine Handpiece
K193264 · Ningbo Hpdove Dental Instruments Co., Ltd. · Aug 2020