Cleared Traditional

K214054 - TP Orthodontics Light-Cure Adhesive System

K214054 is an FDA 510(k) clearance for TP Orthodontics Light-Cure Adhesive System, manufactured by Tp Orthodontics, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K214054 · Tp Orthodontics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
291d
Days
Class 2
Risk

K214054 is an FDA 510(k) clearance for the TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhes.... Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on October 14, 2022 after a review of 291 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 Tp Orthodontics, Inc. devices

FDA 510(k) Submission Details - K214054

510(k) Number K214054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date October 14, 2022
Days to Decision 291 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
164d slower than avg
Panel avg: 127d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 Peers - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 126
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K214054.
BracePaste Fluoride Sealant
K242537 · American Orthodontics Corp. · Aug 2024
3M™ Transbond™ Orthodontic Adhesive
K234043 · 3M Unitek Orthodontic Products · Dec 2023
AlignerFlow LC
K231817 · Voco GmbH · Dec 2023
FiteBac CC OrthoSeal
K210115 · Largent Health, LLC · Jul 2021
Orthocem, Ortho Bite
K192682 · Dentscare Ltda · Aug 2020
BracePaste Band and Build LC
K202276 · American Orthodontics · Aug 2020