Cleared Traditional

K973495 - GLENROE GLOW IN DARK ELASTOMERIC LIGATURES

K973495 is an FDA 510(k) clearance for GLENROE GLOW IN DARK ELASTOMERIC LIGATURES, manufactured by Glenroe. The device is a Class 1 Dental device with product code ECI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K973495 · Glenroe · Dental device
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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

FDA 510(k) Submission Details - K973495

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

ECI Device Classification - Class 1, General Controls

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.

Regulatory Peers - ECI Band, Elastic, Orthodontic

Devices cleared under the same product code (ECI) and FDA review panel - the closest regulatory comparables to K973495.
POWER COINS GLOW IN THE DARK LIGATURES
K980864 · Ortho Kinetics Corp. · Apr 1998
GLENROE CHAIN
K980053 · Glenroe Technologies · Feb 1998
ALASTIK
K940165 · Unitek Corp. · Mar 1994
DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
K935144 · Dentauraum, Inc. · Feb 1994
ALASTIK NS
K923999 · Unitek Corp. · Jun 1993
UNI-STICK PLASTIC LIGATURE, MODIFIED
K926578 · American Orthodontics · Mar 1993