Cleared Traditional

Lubrina 2

K190509 · J. Morita USA, Inc. · Dental
Mar 2020
Decision
369d
Days
Class 1
Risk

About This 510(k) Submission

K190509 is an FDA 510(k) clearance for the Lubrina 2, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on March 4, 2020, 369 days after receiving the submission on March 1, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K190509 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2019
Decision Date March 04, 2020
Days to Decision 369 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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