Cleared Traditional

K061481 - GRENGLOO

K061481 is the FDA 510(k) clearance for GRENGLOO by Ormco Corp.. It is a Class 2 Dental device (product code DYH) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K061481 · Ormco Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
37d
Days
Class 2
Risk

K061481 is an FDA 510(k) clearance for the GRENGLOO. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Ormco Corp. (Newport Beach, US). The FDA issued a Cleared decision on July 6, 2006 after a review of 37 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 Ormco Corp. devices

Submission Details

510(k) Number K061481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2006
Decision Date July 06, 2006
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 127d · This submission: 37d
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 Dental devices follow this clearance model.

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

All 65
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K061481.
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K040375 · Dentsply Intl. · Apr 2004