FDA.reportPublic FDA data

Orthodontic separator

Definition
A non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
GUDID devices
56
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00843471144657The Orthodontic StoreYoung Innovations, Inc.603-0802022-11-01
00843471144664The Orthodontic StoreYoung Innovations, Inc.603-0902022-11-01
00843471144688The Orthodontic StoreYoung Innovations, Inc.603-3002022-11-01
05060772893502Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SBL2020-08-17
05060772893526Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SBS2020-08-17
05060772893588Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SWL2020-08-17
05060772893601Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SWS2020-08-17
10190886101629NAG & H Wire Company, Inc.325-3022025-03-26
10190886101636NAG & H Wire Company, Inc.325-3032025-03-26
10190886101643NAG & H Wire Company, Inc.500-0012025-03-26
10190886101650NAG & H Wire Company, Inc.500-0032025-03-26
10190886101667NAG & H Wire Company, Inc.500-0042025-03-26
10190886103678NAG & H Wire Company, Inc.M926-012025-03-26
00190886101622NAG & H Wire Company, Inc.325-3022025-03-26
00190886101639NAG & H Wire Company, Inc.325-3032025-03-26
00190886101646NAG & H Wire Company, Inc.500-0012025-03-26
00190886101653NAG & H Wire Company, Inc.500-0032025-03-26
00190886101660NAG & H Wire Company, Inc.500-0042025-03-26
00190886103671NAG & H Wire Company, Inc.M926-012025-03-26
00810152822074PRO-ELASTOrtho Pro Dent LLCELS-10002024-11-04
10843471144685The Orthodontic StoreYoung Innovations, Inc.603-3002022-11-01
D8199001630Elastic Separator (80/pk)SPECIALTY APPLIANCES, LLC9001632022-12-05
00190746058905SeparatorsAMERICAN ORTHODONTICS CORPORATION854-2512022-07-22
00190746058912SeparatorsAMERICAN ORTHODONTICS CORPORATION854-251B2022-07-22
D90932530212ELASTOMERIC THREADOrtho Arch Company Inc325-3022021-09-10
00190746170829SeparatorsAMERICAN ORTHODONTICS CORPORATION854-0340802021-06-11
00190746170836SeparatorsAMERICAN ORTHODONTICS CORPORATION854-0340812021-06-11
00192029039120Sep-A-Rings SeparatorsTP ORTHODONTICS INC352-0002021-02-15
00192029039137Sep-A-Rings SeparatorsTP ORTHODONTICS INC352-000C2021-02-15
00192029039168Sep-A-Rings SeparatorsTP ORTHODONTICS INC353-0002021-02-15
00192029039175Sep-A-Rings SeparatorsTP ORTHODONTICS INC353-000C2021-02-15
04560218662064DENTECHDENTECH CORPORATION010710002020-09-24
04560218662071DENTECHDENTECH CORPORATION010720002020-09-24
05060772893519Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SBL2020-08-17
05060772893533Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SBS2020-08-17
05060772893595Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SWL2020-08-17
05060772893618Phoenix SeparatorsPHOENIX ORTHODONTICS INCE-SWS2020-08-17
00190707065416Radiopaque Separating ModulesOrtho Organizers, Inc.4108-8452020-07-02
00190746034411SeparatorsAMERICAN ORTHODONTICS CORPORATION854-2512019-05-16
00190746034428SeparatorsAMERICAN ORTHODONTICS CORPORATION854-251B2019-05-16
00190746146329SeparatorsAMERICAN ORTHODONTICS CORPORATION854-2502019-04-16
00190746146336SeparatorsAMERICAN ORTHODONTICS CORPORATION854-250A2019-04-16
00810033832086AURADONICSAURADONICS INC.500-0012019-12-30
00810033832093AURADONICSAURADONICS INC.500-0022019-12-30
00810033832109AURADONICSAURADONICS INC.500-0032019-12-30
00810033832116AURADONICSAURADONICS INC.500-0042019-12-30
00810033832123AURADONICSAURADONICS INC.500-0052019-12-30
00810033832130AURADONICSAURADONICS INC.500-0062019-12-30
00810033832147AURADONICSAURADONICS INC.500-0072019-12-30
00810033832154AURADONICSAURADONICS INC.500-0082019-12-30
00190707059354ELASTIC SEPARATORSOrtho Organizers, Inc.400-3562019-09-30
00190707043384ClassOneOrtho Organizers, Inc.100-971C12017-11-21
00190707045753Ortho OrganizersOrtho Organizers, Inc.400-3522017-12-21
00190707045760Ortho OrganizersOrtho Organizers, Inc.400-3532017-12-21
00190707057602ELASTIC SEPARATORSOrtho Organizers, Inc.400-3552019-03-07
00190707057619ELASTIC SEPARATORSOrtho Organizers, Inc.400-355L2019-03-07