Cleared Traditional

Ortholock Anchorage Devices

K202691 · Craniofacial Technologies, Inc. · Dental
Apr 2022
Decision
590d
Days
Class 2
Risk

About This 510(k) Submission

K202691 is an FDA 510(k) clearance for the Ortholock Anchorage Devices, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Craniofacial Technologies, Inc. (Bell Canyon, US). The FDA issued a Cleared decision on April 28, 2022, 590 days after receiving the submission on September 15, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K202691 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2020
Decision Date April 28, 2022
Days to Decision 590 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code OAT — Implant, Endosseous, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640
Definition It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.