Cleared Traditional

TUFF TIES

K924140 · Glenroe Technologies · Dental
Apr 1993
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

K924140 is an FDA 510(k) clearance for the TUFF TIES, a Band, Elastic, Orthodontic (Class I — General Controls, product code ECI), submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on April 27, 1993, 252 days after receiving the submission on August 18, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K924140 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1992
Decision Date April 27, 1993
Days to Decision 252 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ECI — Band, Elastic, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410

Similar Devices — ECI Band, Elastic, Orthodontic

All 24
POWER COINS GLOW IN THE DARK LIGATURES
K980864 · Ortho Kinetics Corp. · Apr 1998
GLENROE CHAIN
K980053 · Glenroe Technologies · Feb 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