Cleared Traditional

The Slide

K203712 · Biotex, Inc. · Dental
Jul 2021
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K203712 is an FDA 510(k) clearance for the The Slide, a Device, Jaw Repositioning (Class II — Special Controls, product code LQZ), submitted by Biotex, Inc. (Houston, US). The FDA issued a Cleared decision on July 20, 2021, 211 days after receiving the submission on December 21, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K203712 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2020
Decision Date July 20, 2021
Days to Decision 211 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LQZ — Device, Jaw Repositioning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5570