FDA.reportPublic FDA data

Orthodontic aligner/retainer seater, single-use

Definition
A small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.
GUDID devices
56
Last updated
2026-07-15 00:48:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840456203019JMUJMU DENTAL, INC390010052026-07-06
00840456203026JMUJMU DENTAL, INC390010062026-07-06
00840456203033JMUJMU DENTAL, INC390010072026-07-06
00840456203040JMUJMU DENTAL, INC390010082026-07-06
00840456203057JMUJMU DENTAL, INC390010092026-07-06
00840456203064JMUJMU DENTAL, INC390010102026-07-06
00840456203071JMUJMU DENTAL, INC390010112026-07-06
00840456203088JMUJMU DENTAL, INC390010122026-07-06
00840456203095JMUJMU DENTAL, INC390010132026-07-06
00858813002175PlatypusGLENROE, LLCAC1502026-06-01
00858813002182PlatypusGLENROE, LLCAC150BAG2026-06-01
00858813002199PlatypusGLENROE, LLCAC150-52026-06-01
00858813002205PlatypusGLENROE, LLCAC150-5BAG2026-06-01
00723896021910SmileGoods Right-Bite Aligner SeatersPRACTICON, INC.710981132022-11-07
00843471151273Young SpecialtiesYoung Innovations, Inc.399-0352024-07-11
00843471151280Young SpecialtiesYoung Innovations, Inc.399-0402024-07-11
00843471151297Young SpecialtiesYoung Innovations, Inc.399-0452024-07-11
00843471151303Young SpecialtiesYoung Innovations, Inc.399-0602024-07-11
00843471151310Young SpecialtiesYoung Innovations, Inc.399-0652024-07-11
07333117010000Rodney Aligner Seaters, mintGestenco International ABRAS-0012026-04-30
07333117010017Rodney Aligner Seaters, lemonGestenco International ABRAS-0022026-04-30
07333117010024Rodney Aligner Seaters, melonGestenco International ABRAS-0032026-04-30
07333117010369Rodney Aligner SeatersGestenco International ABRAS-0042026-04-30
08906139322094Taglus Ortho ChewiesLAXMI DENTAL LIMITEDVS5392026-01-09
D78855016000011ChewiesGc Orthodontics America Inc.55-0160-00012023-01-25
D78855016000021ChewiesGc Orthodontics America Inc.55-0160-00022023-01-25
D78855016000031ChewiesGc Orthodontics America Inc.55-0160-00032023-01-25
D78855016000041ChewiesGc Orthodontics America Inc.55-0160-00042023-01-25
D78855016001551RodneyGc Orthodontics America Inc.55-0160-01552023-03-30
D78855016005051ClenchyGc Orthodontics America Inc.55-0160-05052023-03-14
D832ATS10M1PlasdentPLASDENT CORPORATIONATS-10M2022-01-27
D832ATS11PlasdentPLASDENT CORPORATIONATS-12022-01-27
D832ATS2X1PlasdentPLASDENT CORPORATIONATS-2X2022-01-27
D832ATS3X1PlasdentPLASDENT CORPORATIONATS-3X2022-01-27
D832ATS4X1PlasdentPLASDENT CORPORATIONATS-4X2022-01-27
D832ATS5X1PlasdentPLASDENT CORPORATIONATS-5X2022-01-27
D832ATSA1PlasdentPLASDENT CORPORATIONATS-A2022-01-27
D89260705400302ORTHO ALIGNER TRAY SEATERSMAXILL, INC.60705400302022-09-08
D89260705400312ORTHO ALIGNER TRAY SEATERSMAXILL, INC.60705400312022-09-08
D89260705400322ORTHO ALIGNER TRAY SEATERSMAXILL, INC.60705400322022-09-08
G859PT20260010Clear Moves AlignerCLEAR MOVES ALIGNERSPT-2026-0012026-05-22
28906139322098Taglus Ortho ChewiesLAXMI DENTAL LIMITEDVS5392026-01-09
00850058951362Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.Unscented - Purple2024-10-08
00850058951379Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.Unscented - White2024-10-08
00723896026847SMILEGOODS ALIGNER CHEWIES MINT 24 PACKPRACTICON, INC.71098133 MIN2024-08-07
00723896026854SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACKPRACTICON, INC.71098133 UNS2024-08-07
00723896026878SMILEGOODS ALIGNER CHEWIES MINT PRACTICON, INC.71098134 MIN2024-08-07
00723896026885SMILEGOODS ALIGNER CHEWIES UNSCENTED PRACTICON, INC.71098134 UNS2024-08-07
00723896026892SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACKPRACTICON, INC.71098133 AST2024-08-07
00723896026908SMILEGOODS ALIGNER CHEWIES ASSORTED PRACTICON, INC.71098134 AST2024-08-07
07908611206053ORTHOCHEWIEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA60.20.10032024-02-27
D78855016001550RodneyGc Orthodontics America Inc.55-0160-01552023-03-30
D78855016000010ChewiesGc Orthodontics America Inc.55-0160-00012023-01-25
D78855016000020ChewiesGc Orthodontics America Inc.55-0160-00022023-01-25
D78855016000030ChewiesGc Orthodontics America Inc.55-0160-00032023-01-25
D78855016000040ChewiesGc Orthodontics America Inc.55-0160-00042023-01-25