Cleared Traditional

Oral Surgery Contra

K211584 · Nakanishi, Inc. · Dental
Aug 2021
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K211584 is an FDA 510(k) clearance for the Oral Surgery Contra, a Handpiece, Rotary Bone Cutting (Class II — Special Controls, product code KMW), submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on August 19, 2021, 87 days after receiving the submission on May 24, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K211584 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2021
Decision Date August 19, 2021
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KMW — Handpiece, Rotary Bone Cutting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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