FDA.reportPublic FDA data

Orthodontic palate expander/teeth aligner, self-removable

Definition
An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism with clasps and/or wires. It is not fixed to the oral cavity so that it can be temporarily removed and reapplied by the patient during the treatment period (e.g., for eating). This is a reusable device.
GUDID devices
164
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.AEA2026-04-13
D82850000100Schwarz - Upper W/GearFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000102022-12-12
D82850000120Pre Bio-BlockFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000122022-12-12
D82850000150Schwarz W/Duo-T Springs - LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000152022-12-12
D82850000200Schwarz - Lower W/GearFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000202022-12-12
D82850000400E-Regainer - UpperFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000402022-12-12
D82850000500E-Regainer - LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000502022-12-12
D82850000600Schwarz/E-Regainer Combo-UpperFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000602022-12-12
D82850000700Schwarz/E-Regainer Combo-LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000702022-12-12
D82850000800Schwarz 3-Way - Upper W/GearFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000802022-12-12
D828500008503-Way Schwarz W/Duo-T SpringsFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50000852022-12-12
D82850001000Schwarz Fan-Gear - UpperFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001002022-12-12
D82850001100Schwarz/Sagittal Combo - UpperFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001102022-12-12
D82850001200Schwarz/Sagittal Combo - LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001202022-12-12
D82850001300Sagittal - Upper W/GearFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001302022-12-12
D82850001400Sagittal - Lower W/GearFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001402022-12-12
D82850001500Nord CrossbiteFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001502022-12-12
D82850001600Han ApplianceFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001602022-12-12
D82850001700Jackson - LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001702022-12-12
D82850001710Jackson - UpperFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001712022-12-12
D82850001920Adult Split BionatorFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50001922022-12-12
D82850002100ActivatorFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50002102022-12-12
D82850002200BionatorFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50002202022-12-12
D82850002210Mini BionatorFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50002212022-12-12
D82850002300Orthopedic CorrectorFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50002302022-12-12
D82850002700Crozat - UpperFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50002702022-12-09
D82850002800Crozat - LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50002802022-12-09
D82850003000AlfFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50003002022-12-09
D82850003010N-SagittalFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC50003012022-12-12
D82853003730Removable LVI Anterior Remodeling ApplianceFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC53003732022-12-12
D82853003740Removable 3-Way LVI Anterior Remodeling ApplianceFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC53003742022-12-13
D82854003090Tandem Traction BowFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC54003092022-12-09
00810126380029Super Spring Speed AlignerDigital Dental Laboratories, Inc00292024-07-08
00810126380074Bowbeer AppliancesDigital Dental Laboratories, Inc00742024-07-08
00810126380098Bite Place with 2 Adams ClaspsDigital Dental Laboratories, Inc00982024-07-08
00888515225169BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.85-11402024-02-28
00888515225176BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.85-11502024-02-28
00816063021391Invisalign Palatal ExpanderAlign Technology, Inc.90312024-01-03
00889989038460FrankelALLESEE AOA-PRO3000-00132023-03-13
00889989038477BionatorALLESEE AOA-PRO3000-00142023-03-13
00889989038484Orthopedic CorrectorALLESEE AOA-PRO3000-00152023-03-13
00889989038491Twin BlockALLESEE AOA-PRO3000-00162023-03-13
00889989038507ActivatorALLESEE AOA-PRO3000-00172023-03-13
00889989038514ACCO ExpanderALLESEE AOA-PRO3000-00182023-03-13
00889989038521Shamey ExpanderALLESEE AOA-PRO3000-00192023-03-13
00889989038538Nord ExpanderALLESEE AOA-PRO3000-00202023-03-13
00889989038545Jackson ExpanderALLESEE AOA-PRO3000-00212023-03-13
00889989038552MAH Freedom ApplianceALLESEE AOA-PRO3000-00222023-03-13
00889989038675Schwarz ApplianceALLESEE AOA-PRO3000-00432023-03-13
00889989038682Sagittal ApplianceALLESEE AOA-PRO3000-00442023-03-13
10843471144807The Orthodontic StoreYoung Innovations, Inc.615-6002022-11-02
10843471144838The Orthodontic StoreYoung Innovations, Inc.615-7002022-11-02
10843471144876The Orthodontic StoreYoung Innovations, Inc.615-9002022-11-02
10843471144883The Orthodontic StoreYoung Innovations, Inc.615-9502022-11-02
D9110100A130ORTHOSOURCEORTHOSOURCE0100A-132022-10-26
D9110100B100ORTHOSOURCEORTHOSOURCE0100B-102022-10-26
D9111002K100ORTHOSOURCEORTHOSOURCE1002K-102022-10-26
D9111002K140ORTHOSOURCEORTHOSOURCE1002K-142022-10-26
D9111003K100ORTHOSOURCEORTHOSOURCE1003K-102022-10-26
D9111003K140ORTHOSOURCEORTHOSOURCE1003K-142022-10-26
D91110160ORTHOSOURCEORTHOSOURCE10162022-10-26
D91110170ORTHOSOURCEORTHOSOURCE10172022-10-26
D9111018FA0ORTHOSOURCEORTHOSOURCE1018FA2022-10-26
D9111019FA0ORTHOSOURCEORTHOSOURCE1019FA2022-10-26
D9111110A150ORTHOSOURCEORTHOSOURCE1110A-152022-10-26
D9111110B130ORTHOSOURCEORTHOSOURCE1110B-132022-10-26
D9111110C100ORTHOSOURCEORTHOSOURCE1110C-102022-10-26
D9111110D90ORTHOSOURCEORTHOSOURCE1110D-92022-10-26
D9111110E170ORTHOSOURCEORTHOSOURCE1110E-172022-10-26
D9111110M150ORTHOSOURCEORTHOSOURCE1110M-152022-10-26
D9111110M170ORTHOSOURCEORTHOSOURCE1110M-172022-10-26
D9111110M220ORTHOSOURCEORTHOSOURCE1110M-222022-10-26
D91111200ORTHOSOURCEORTHOSOURCE11202022-10-26
D9111120R0ORTHOSOURCEORTHOSOURCE1120R2022-10-26
D91111210ORTHOSOURCEORTHOSOURCE11212022-10-26
D9111121R0ORTHOSOURCEORTHOSOURCE1121R2022-10-26
D91111220ORTHOSOURCEORTHOSOURCE11222022-10-26
D9111122R0ORTHOSOURCEORTHOSOURCE1122R2022-10-26
D91118440ORTHOSOURCEORTHOSOURCE18442022-10-26
D91118450ORTHOSOURCEORTHOSOURCE18452022-10-26