ECI · Class I · 21 CFR 872.5410

FDA Product Code ECI: Band, Elastic, Orthodontic

Leading manufacturers include Jon-Ko Products, Inc., Glenroe Technologies and Unitek Corp..

25
Total
25
Cleared
144d
Avg days
1978
Since

FDA 510(k) Cleared Band, Elastic, Orthodontic Devices (Product Code ECI)

25 devices
1–24 of 25
Cleared Apr 20, 1998
POWER COINS GLOW IN THE DARK LIGATURES
K980864
Ortho Kinetics Corp.
Dental · 46d
Cleared Feb 24, 1998
GLENROE CHAIN
K980053
Glenroe Technologies
Dental · 49d
Cleared Dec 01, 1997
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
K973495
Glenroe
Dental · 76d
Cleared May 24, 1995
ORTHODONTIC ELASTOMERIC LAGATURE MODULE
K943419
Jon-Ko Products, Inc.
Dental · 313d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC TUBE/THREAD
K943417
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE
K943418
Jon-Ko Products, Inc.
Dental · 312d
Cleared May 23, 1995
ORTHODONTIC ELASTOMERIC CHAIN
K943420
Jon-Ko Products, Inc.
Dental · 312d
Cleared Mar 07, 1994
ALASTIK
K940165
Unitek Corp.
Dental · 60d
Cleared Feb 14, 1994
PRO'S NEO-LASTICS
K932298
Professional Positioners, Inc.
Dental · 279d
Cleared Feb 04, 1994
DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
K935144
Dentauraum, Inc.
Dental · 99d
Cleared Sep 20, 1993
ORTHODONTIC ELASTOMER
K932319
Gac Intl., Inc.
Dental · 132d
Cleared Jul 22, 1993
GLENROE CHAIN
K931462
Glenroe Technologies, Inc.
Dental · 120d
Cleared Jun 24, 1993
ALASTIK NS
K923999
Unitek Corp.
Dental · 318d
Cleared May 27, 1993
SINGLES
K930453
Nexadental
Dental · 120d
Cleared Apr 27, 1993
TUFF TIES
K924140
Glenroe Technologies
Dental · 252d
Cleared Apr 08, 1993
GLENROE ORTHO SEPS
K924139
Glenroe Technologies
Dental · 233d
Cleared Mar 31, 1993
UNI-STICK PLASTIC LIGATURE, MODIFIED
K926578
American Orthodontics
Dental · 191d

About Product Code ECI - Regulatory Context