Cleared Traditional

K994309 - SOLO ORTHO 2

K994309 is an FDA 510(k) clearance for SOLO ORTHO 2, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K994309 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
87d
Days
Class 2
Risk

K994309 is an FDA 510(k) clearance for the SOLO ORTHO 2. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on March 17, 2000 after a review of 87 days - a notably fast clearance 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: 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 Sybron Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K994309

510(k) Number K994309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1999
Decision Date March 17, 2000
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 136
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K994309.
IMPROVED ENLIGHT LV
K001881 · Sybron Dental Specialties, Inc. · Aug 2000
LIGHT-CURED ORTHODONTIC BAND CEMENT
K001446 · Scientific Pharmaceuticals, Inc. · Jul 2000
LIGHT BOND (QUICK CURE)
K001048 · Reliance Orthodontic Products, Inc. · Apr 2000
SOLO ORTHO
K990743 · Sybron Dental Specialties, Inc. · Jun 1999
SMARTBOND
K981036 · Gac Intl., Inc. · Apr 1999
SOLO PLUS ORTHO
K990252 · Sybron Dental Specialties, Inc. · Feb 1999