Cleared Traditional

K980053 - GLENROE CHAIN

K980053 is an FDA 510(k) clearance for GLENROE CHAIN, manufactured by Glenroe Technologies. The device is a Class 1 Dental device with product code ECI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K980053 · Glenroe Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
49d
Days
Class 1
Risk

K980053 is an FDA 510(k) clearance for the GLENROE CHAIN. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on February 24, 1998 after a review of 49 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.

FDA 510(k) Submission Details - K980053

510(k) Number K980053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1998
Decision Date February 24, 1998
Days to Decision 49 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
79d faster than avg
Panel avg: 128d · This submission: 49d
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

All 16
Devices cleared under the same product code (ECI) and FDA review panel - the closest regulatory comparables to K980053.
POWER COINS GLOW IN THE DARK LIGATURES
K980864 · Ortho Kinetics Corp. · Apr 1998
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
K973495 · Glenroe · Dec 1997
ORTHODONTIC ELASTOMERIC LAGATURE MODULE
K943419 · Jon-Ko Products, Inc. · May 1995
ORTHODONTIC ELASTOMERIC TUBE/THREAD
K943417 · Jon-Ko Products, Inc. · May 1995
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE
K943418 · Jon-Ko Products, Inc. · May 1995
ORTHODONTIC ELASTOMERIC CHAIN
K943420 · Jon-Ko Products, Inc. · May 1995
K980053 · GLENROE CHAIN
Download PDF Glenroe Technologies