Cleared Traditional

K032195 - DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT

K032195 is an FDA 510(k) clearance for DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT, manufactured by Dentaurum. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K032195 · Dentaurum · Dental device
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Oct 2003
Decision
81d
Days
Class 2
Risk

K032195 is an FDA 510(k) clearance for the DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Dentaurum (Newtown, US). The FDA issued a Cleared decision on October 7, 2003 after a review of 81 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 Dentaurum devices

FDA 510(k) Submission Details - K032195

510(k) Number K032195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2003
Decision Date October 07, 2003
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
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 135
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K032195.
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
K040548 · Harry J. Bosworth Co. · Mar 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · Dentsply Intl. · Feb 2004
EVOLVE
K033551 · Reliance Orthodontic Products, Inc. · Dec 2003
OPTIBAND LC
K032407 · Sybron Dental Specialties, Inc. · Oct 2003
ENVISION
K032042 · Sybron Dental Specialties, Inc. · Sep 2003
S & C -BRACKET ADHESIVES
K031420 · S & C Polymer GmbH · Aug 2003