Cleared Traditional

Symetri Clear (K172845) - FDA 510(k) Clearance

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

K172845 · Ormco Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
134d
Days
Class 2
Risk

K172845 is an FDA 510(k) clearance for the Symetri Clear. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Ormco Corporation (Orange, US). The FDA issued a Cleared decision on January 31, 2018 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 Ormco Corporation devices

Submission Details

510(k) Number K172845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2017
Decision Date January 31, 2018
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.
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 - NJM Bracket, Ceramic, Orthodontic

All 21
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K172845.
Signature Orthodontic System
K181271 · Signature Orthodontics · Jun 2018
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K180404 · 3M Healthcare · Mar 2018
Carriere SLX 3D Clear
K173440 · Ortho Organizers, Inc. · Mar 2018
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · Dentsply Intl. · Nov 2004
ORTHODONTIC CERAMIC BRACKETS
K042178 · Dentsply Intl. · Aug 2004