Cleared Traditional

Blue Sky Bio TAD (K201919) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201919 · Blue Sky Bio, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2020
Decision
160d
Days
Class 2
Risk

K201919 is an FDA 510(k) clearance for the Blue Sky Bio TAD. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Blue Sky Bio, LLC (Libertyville, US). The FDA issued a Cleared decision on December 17, 2020 after a review of 160 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Blue Sky Bio, LLC devices

Submission Details

510(k) Number K201919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2020
Decision Date December 17, 2020
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAT Implant, Endosseous, Orthodontic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Compliance4Devices
Juan Tezak

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 - OAT Implant, Endosseous, Orthodontic

All 18
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K201919.
Ortho MI System
K211992 · Osteonic Co., Ltd. · Oct 2021
Syntec Orthodontic Mini Screw Extended System
K202790 · Syntec Scientific Corporation · Sep 2021
OBS Anchorage Screw, Biokey Anchorage Screw
K202278 · Bomei Co, Ltd. · Jan 2021
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K191041 · Gni Co., Ltd. · Aug 2020
Bio-TackS Orthodontic Mini Implant
K190871 · Biocetec Co., Ltd. · Jan 2020
BIO-RAY A-1 Anchor Screw System
K182929 · Microware Precision Co., Ltd. · Nov 2019