Medical Device Manufacturer · US , Sheboygan , WI

American Orthodontics

44 submissions · 44 cleared · Since 1989
44
Total
44
Cleared
0
Denied

American Orthodontics — FDA 510(k) Submissions

American Orthodontics has submitted 44 FDA 510(k) premarket notifications since 1989, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bracket, Metal, Orthodontic, Adhesive, Bracket And Tooth Conditioner, Resin, Bracket, Ceramic, Orthodontic, Agent, Tooth Bonding, Resin, Positioner, Tooth, Preformed . Use the specialty filter in the sidebar to narrow results.

44 devices
1–25 of 44
Cleo
K232011 · NJM Bracket, Ceramic,... · Dental
Jul 2023 1d
BracePaste Band and Build LC
K202276 · DYH Adhesive, Bracket And... · Dental
Aug 2020 3d
BracePaste MTP Light Cure Primer
K181910 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2018 90d
Acid Etchant
K172953 · KLE Agent, Tooth Bonding, Resin · Dental
Feb 2018 133d
BracePaste Adhesive
K160782 · DYH Adhesive, Bracket And... · Dental
Oct 2016 206d
Wire Sterilization Package with Indicators
K143117 · FRG Wrap, Sterilization · General Hospital
Oct 2015 364d
EMPOWER CLEAR
K122753 · NJM Bracket, Ceramic,... · Dental
Dec 2012 98d
RADIANCE
K080749 · NJM Bracket, Ceramic,... · Dental
Aug 2008 140d
PLASTIC CHAIN
K925012 · EJF Bracket, Metal, Orthodontic · Dental
Sep 1993 346d
ORTHODONTIC BITE
K922984 · LRK Device, Anti-snoring · Dental
Mar 1993 282d
UNI-STICK PLASTIC LIGATURE, MODIFIED
K926578 · ECI Band, Elastic, Orthodontic · Dental
Mar 1993 191d
ORTHODONTIC METAL BRACKET
K923261 · EJF Bracket, Metal, Orthodontic · Dental
Dec 1992 154d
MOLAR DISTALIZING ASSEMBLY
K912417 · DYJ Retainer, Screw... · Dental
Dec 1991 203d
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
K904128 · KMY Positioner, Tooth, Preformed · Dental
Nov 1990 65d
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · EJF Bracket, Metal, Orthodontic · Dental
Aug 1990 90d
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · EJF Bracket, Metal, Orthodontic · Dental
Jun 1990 122d
BANDTITE GLASS IONOMER CEMENT
K896249 · EMA Cement, Dental · Dental
Jan 1990 88d
ORTHO-KEV APPLIANCE REINFORCING SYSTEM
K895714 · EBI Resin, Denture, Relining,... · Dental
Dec 1989 87d
FORCE II
K895163 · DYH Adhesive, Bracket And... · Dental
Oct 1989 66d
UNI-STICK PLASTIC LIGATURES
K891331 · EJF Bracket, Metal, Orthodontic · Dental
Oct 1989 220d
KORN MANDIBULAR ADVANCER
K893482 · EJF Bracket, Metal, Orthodontic · Dental
Oct 1989 161d
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK
K893655 · EJF Bracket, Metal, Orthodontic · Dental
Aug 1989 100d
BONDABLE RETAINER AND SPACE MAINTAINER
K893483 · EJF Bracket, Metal, Orthodontic · Dental
Jul 1989 71d
MULTIPHASE ORTHODONTIC WIRE
K893484 · EJF Bracket, Metal, Orthodontic · Dental
Jul 1989 71d
PLASTIC FORCE MODULE
K893550 · EJF Bracket, Metal, Orthodontic · Dental
Jul 1989 67d
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