Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device bracket, metal, orthodontic
Regulation Description Orthodontic appliance and accessories.
Product CodeEJF
Regulation Number 872.5410
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 22
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Difficult to remove 3
No Known Device Problem 3
Improper or incorrect procedure or method 2
Patient-device incompatibility 2
Difficult to insert 1
Solder joint failure 1
Total Device Problems 12

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 2 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ormco Corporation III Mar-01-2012
2 Ormco/Sybronendo II Apr-02-2014
3 Ormco/Sybronendo III Oct-23-2012
4 Ultradent Products, Inc. III Feb-22-2013

-
-