FDA.reportPublic FDA data

AMERICAN ORTHODONTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21266832126683AMERICAN ORTHODONTICS1Y2026-01-013524 Washington Ave SHEBOYGAN WI US 53081

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00190746007835Procelain Conditioner - PORCELAIN CONDITIONER 6 CC+1(800)558-7687info@americanortho.com
00190746148354Superelastic Titanium Memory - WIRE NITI FORM II UPPER 016X016 IND 10/PK800-558-7687info@americanortho.com
00190746148354Superelastic Titanium Memory - WIRE NITI FORM II UPPER 016X016 IND 10/PK+1(800)558-7687info@americanortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
59461057329034K963205ALGINMAX, ORTHOCHROMEELW1996-10-29
59461456699049K961417GC FUJI ORTHODYH1996-05-24
59461082597890K940410NEW GEAR RELEASABLE HEADGEARDZB1994-03-10
59461726443414K922499REFLECTIONS - CERAMIC DENTAL BRACKETEJF1992-07-30
59461723567201K896249BANDTITE GLASS IONOMER CEMENTEMA1990-01-26
59461931906123K895386GLASIONEMA1990-04-16
59461289018793K893542DIASTEMA CLOSING KITEJF1989-06-23
59461046836205K893037NO-MIX 30 ORTHODONTIC BONDING SYSTEMSDYH1989-06-12
59461086199824K891372ORTHODONTIC PLASTIC BRACKETDYW1989-03-31
59461181967934K872569TEMREX ETCHING GELEBF1987-07-21
59461720649962K831495CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHODYH1983-07-18
59461117070567K242537BracePaste Fluoride SealantDYH2024-08-27
59461413539067K232011CleoNJM2023-07-07
59461011221632K202276BracePaste Band and Build LCDYH2020-08-14
59461598751424K181910BracePaste MTP Light Cure PrimerKLE2018-10-15
59461087043814K172953Acid EtchantKLE2018-02-06
59461337595381K160782BracePaste AdhesiveDYH2016-10-14
59461517399984K122753EMPOWER CLEARNJM2012-12-14
59462032999230K121824ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2ELW2012-08-23
59461790983149K080749RADIANCENJM2008-08-04
59461984698567K032465MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINIEBZ2003-10-21
59461684795213K001446LIGHT-CURED ORTHODONTIC BAND CEMENTDYH2000-07-21
59461084371100K000358MULTI ADJUSTABLE FACE MASKDZB2000-06-09
59461844148783
59462011547120
59461068885053
59461086306673
59461192105127
59461206575700
59461236896962
59461267258283
59461338807507
59461370129332
59461505189991
59461556003678
59461578525614
59461595453164
59461610231167
59461642833911
59461705664017
59461797313426
59461819689756
59461843296933
59461858227543
59461862148780
59461870855383
59461956577460
59461999721336
59462019658848
59462072166408

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYH72024-08-27
NJM32023-07-07
KLE22018-10-15
ELW22012-08-23
DZB22000-06-09
EJF21992-07-30
EMA21990-04-16
EBZ12003-10-21
DYW11989-03-31
EBF11987-07-21

PMN#

Cleo

2023-07-07

American Orthodontics

45 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next