Cleared Traditional

K183147 - BrackFix

K183147 is an FDA 510(k) clearance for BrackFix, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K183147 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
108d
Days
Class 2
Risk

K183147 is an FDA 510(k) clearance for the BrackFix. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on March 1, 2019 after a review of 108 days - within the typical 510(k) review window.

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 Voco GmbH devices

FDA 510(k) Submission Details - K183147

510(k) Number K183147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2018
Decision Date March 01, 2019
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 127d · This submission: 108d
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 141
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K183147.
Orthocem, Ortho Bite
K192682 · Dentscare Ltda · Aug 2020
BracePaste Band and Build LC
K202276 · American Orthodontics · Aug 2020
GlassLok Kits, GlassLok Powder, GlassLok Liquid
K193388 · Reliance Orthodontic Products, Inc. · Apr 2020
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K173020 · Pulpdent Corporation · Jan 2018
BracePaste Adhesive
K160782 · American Orthodontics · Oct 2016
Quantum LB
K161684 · Reliance Orthodontic Products, Inc. · Oct 2016