Cleared Traditional

GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (K973495) - FDA 510(k) Clearance

Class I Dental device.

K973495 · Glenroe · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
76d
Days
Class 1
Risk

K973495 is an FDA 510(k) clearance for the GLENROE GLOW IN DARK ELASTOMERIC LIGATURES. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by Glenroe (Bradenton, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 Glenroe devices

Submission Details

510(k) Number K973495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1997
Decision Date December 01, 1997
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECI Band, Elastic, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.