Company ยท US
American Orthodontics
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2026. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EJF | Bracket, Metal, Orthodontic | 22 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 8 |
| NJM | Bracket, Ceramic, Orthodontic | 3 |
| KLE | Agent, Tooth Bonding, Resin | 2 |
| KMY | Positioner, Tooth, Preformed | 2 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 1 |
| DYW | Bracket, Plastic, Orthodontic | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
| ECI | Band, Elastic, Orthodontic | 1 |
| EMA | Cement, Dental | 1 |
| FJF | Detector, Air Bubble | 1 |
| FRG | Wrap, Sterilization | 1 |
| KHR | Absorber, Saliva, Paper | 1 |
| LRK | Device, Anti-Snoring | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2026 | K261840 | BracePaste Prime Plus American Orthodontics | DYH |
| Aug 27, 2024 | K242537 | BracePaste Fluoride Sealant American Orthodontics Corp. | DYH |
| Jul 7, 2023 | K232011 | Cleo American Orthodontics | NJM |
| Aug 14, 2020 | K202276 | BracePaste Band and Build LC American Orthodontics | DYH |
| Oct 15, 2018 | K181910 | BracePaste MTP Light Cure Primer American Orthodontics | KLE |
| Feb 6, 2018 | K172953 | Acid Etchant American Orthodontics | KLE |
| Oct 14, 2016 | K160782 | BracePaste Adhesive American Orthodontics | DYH |
| Oct 29, 2015 | K143117 | Wire Sterilization Package with Indicators American Orthodontics | FRG |
| Dec 14, 2012 | K122753 | EMPOWER CLEAR American Orthodontics | NJM |
| Aug 4, 2008 | K080749 | RADIANCE American Orthodontics | NJM |
| Sep 13, 1993 | K925012 | PLASTIC CHAIN American Orthodontics | EJF |
| Mar 31, 1993 | K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED American Orthodontics | ECI |
| Mar 31, 1993 | K922984 | ORTHODONTIC BITE American Orthodontics | LRK |
| Dec 3, 1992 | K923261 | ORTHODONTIC METAL BRACKET American Orthodontics | EJF |
| Dec 20, 1991 | K912417 | MOLAR DISTALIZING ASSEMBLY American Orthodontics | DYJ |
| Nov 9, 1990 | K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER American Orthodontics | KMY |
| Aug 6, 1990 | K902064 | MODIFIED UNI-STICK PLASTIC LIGATURE American Orthodontics | EJF |
| Jun 1, 1990 | K900488 | MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE American Orthodontics | EJF |
| Jan 26, 1990 | K896249 | BANDTITE GLASS IONOMER CEMENT American Orthodontics | EMA |
| Dec 21, 1989 | K895714 | ORTHO-KEV APPLIANCE REINFORCING SYSTEM American Orthodontics | EBI |
| Oct 27, 1989 | K895163 | FORCE II American Orthodontics | DYH |
| Oct 16, 1989 | K891331 | UNI-STICK PLASTIC LIGATURES American Orthodontics | EJF |
| Oct 12, 1989 | K893482 | KORN MANDIBULAR ADVANCER American Orthodontics | EJF |
| Aug 23, 1989 | K893655 | KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK American Orthodontics | EJF |
| Jul 14, 1989 | K893555 | X-RING AND SPEED STIX PLASTIC LIGATURES American Orthodontics | EJF |
| Jul 14, 1989 | K893550 | PLASTIC FORCE MODULE American Orthodontics | EJF |
| Jul 14, 1989 | K893484 | MULTIPHASE ORTHODONTIC WIRE American Orthodontics | EJF |
| Jul 14, 1989 | K893483 | BONDABLE RETAINER AND SPACE MAINTAINER American Orthodontics | EJF |
| Jun 23, 1989 | K893654 | MEMORY CHAIN American Orthodontics | EJF |
| Jun 23, 1989 | K893549 | X-RING SEPARATORS American Orthodontics | EJF |
| Jun 23, 1989 | K893542 | DIASTEMA CLOSING KIT American Orthodontics | EJF |
| Jun 23, 1989 | K893396 | AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM American Orthodontics | DYH |
| Jun 21, 1989 | K893255 | SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE American Orthodontics | DYH |
| Jun 12, 1989 | K893037 | NO-MIX 30 ORTHODONTIC BONDING SYSTEMS American Orthodontics | DYH |
| May 11, 1989 | K891775 | MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES American Orthodontics | EJF |
| May 10, 1989 | K891327 | NICKLE-TITANIUM ORTHODONTIC WIRE American Orthodontics | FJF |
| May 2, 1989 | K891599 | FILAFLEX ORTHODONTIC WIRE American Orthodontics | EJF |
| May 1, 1989 | K890536 | JASPER JUMPER KIT American Orthodontics | EJF |
| Apr 17, 1989 | K891354 | ORTHODONTIC COTTON ROLL HOLDERS American Orthodontics | KHR |
| Apr 17, 1989 | K890656 | LIP BUMPER American Orthodontics | EJF |
| Apr 14, 1989 | K891484 | ORTHODONTIC WRAP-AROUND HAWLEY RETAINER American Orthodontics | EJF |
| Apr 7, 1989 | K891592 | ORTHODONTIC ARCH AND SURGICAL HOOKS American Orthodontics | EJF |
| Mar 31, 1989 | K891372 | ORTHODONTIC PLASTIC BRACKET American Orthodontics | DYW |
| Mar 31, 1989 | K891328 | PREFORMED TEMPLATE FOR TOOTH POSITIONER American Orthodontics | KMY |
| Mar 17, 1989 | K890581 | THE CLARK LIP SHIELD American Orthodontics | EJF |
| Mar 13, 1989 | K890145 | 20/20 ORTHODONTIC CERAMIC BRACKET American Orthodontics | EJF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||