Cleared Traditional

HELIOSIT-ORTHODONTIC (K823409) - FDA 510(k) Clearance

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

K823409 · Vivadent (Usa), Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
67d
Days
Class 2
Risk

K823409 is an FDA 510(k) clearance for the HELIOSIT-ORTHODONTIC. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Vivadent (Usa), Inc. (Amherst, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 872.3750 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vivadent (Usa), Inc. devices

Submission Details

510(k) Number K823409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date January 21, 1983
Days to Decision 67 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 110d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Ophthalmic devices follow this clearance model.

Regulatory Peers - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 192
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K823409.
BracePaste Prime Plus
K261840 · American Orthodontics · Jun 2026
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
K250015 · Ormco Corporation · Jan 2025
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
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
K214054 · Tp Orthodontics, Inc. · Oct 2022