FDA.reportPublic FDA data

Orthodontic appliance relief material

Definition
A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.
GUDID devices
190
Last updated
2026-07-17 21:59:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840456200193JMUJMU DENTAL, INC514040032026-06-22
00840456224144JMUJMU DENTAL, INC101140012026-06-22
00840456224151JMUJMU DENTAL, INC514040012026-06-22
00840456224168JMUJMU DENTAL, INC514040022026-06-22
00840456224175JMUJMU DENTAL, INC514040042026-06-22
00840456224182JMUJMU DENTAL, INC514040052026-06-22
00047701001202DentekDenTek Oral Care, Inc.00038904806A2020-10-06
00070942306799GUM®SUNSTAR AMERICAS, INC.1242022-11-10
00190707143008Ortho Performance®Ortho Organizers, Inc.600-0012025-09-30
00190707143015Ortho Performance®Ortho Organizers, Inc.600-0022025-09-30
00190707143022Ortho Performance®Ortho Organizers, Inc.600-0032025-09-30
00190707143039Ortho Performance®Ortho Organizers, Inc.600-0052025-09-30
00190707143046Ortho Performance®Ortho Organizers, Inc.600-0062025-09-30
00190707143053Ortho Performance®Ortho Organizers, Inc.600-0072025-09-30
00190707143060Ortho Performance®Ortho Organizers, Inc.600-0082025-09-30
00190707143077Ortho Performance®Ortho Organizers, Inc.600-0092025-09-30
00190707143084Ortho Performance®Ortho Organizers, Inc.600-0102025-09-30
00190707143091Ortho Performance®Ortho Organizers, Inc.600-0132025-09-30
00190707149048Comfort Cover™Ortho Organizers, Inc.981652025-10-01
00190707192969Ortho Technology®Ortho Organizers, Inc.98165D2025-10-23
00190707193218Orthosil™Ortho Organizers, Inc.600-0502025-10-23
006522211005663M™ Wax-Pak™3M UNITEK CORPORATION603-0632022-12-08
00840326403891The Orthodontic StoreYoung Innovations, Inc.145-022022-11-01
00840326416617Young SpecialtiesYoung Innovations, Inc.399-951-B2022-11-24
00843471113646The Orthodontic StoreYoung Innovations, Inc.399-7102022-11-01
00843471137581Plak SmackerYoung Innovations, Inc.104592024-12-10
07895742191559MorelliDental Morelli Ltda35.33.0012021-04-30
10190886106303N/AG & H Wire Company, Inc.PWX7362023-10-09
10190886135495NAG & H Wire Company, Inc.EB-252025-03-31
10190886135556NAG & H Wire Company, Inc.700-1112025-03-31
10190886135631NAG & H Wire Company, Inc.700-0992025-03-31
10190886135655NAG & H Wire Company, Inc.PWX5362025-03-31
10190886135662NAG & H Wire Company, Inc.PWX6362025-03-31
10190886135679NAG & H Wire Company, Inc.EB-25G2025-03-31
10190886135686NAG & H Wire Company, Inc.EB-25PBG2025-03-31
10190886140697NAG & H Wire Company, Inc.M350-022025-03-31
10190886154083NAG & H Wire Company, Inc.UWX11642025-03-31
10190886154175NAG & H Wire Company, Inc.PWX5372025-03-31
D78855D91000001OrVanceGc Orthodontics America Inc.55-D910-00002022-01-26
D78855D91100001OrVanceGc Orthodontics America Inc.55-D911-00002022-01-26
D78855K50000001OrVanceGc Orthodontics America Inc.55-K500-00002022-01-26
D78855K60000001OrVanceGc Orthodontics America Inc.55-K600-00002022-01-26
D78855K71000001OrVanceGc Orthodontics America Inc.55-K710-00002022-01-26
D78855K81000001OrVanceGc Orthodontics America Inc.55-K810-00002022-01-26
E53555D91000001Ortho DotsGc Orthodontics America Inc.55-D910-00002021-08-26
E53555K71000001Ortho DotsGc Orthodontics America Inc.55-K710-00002021-08-26
E53555K81000001Ortho DotsGc Orthodontics America Inc.55-K810-00002021-08-26
10190707143005Ortho Performance®Ortho Organizers, Inc.600-0012025-09-30
10190707143012Ortho Performance®Ortho Organizers, Inc.600-0022025-09-30
10190707143029Ortho Performance®Ortho Organizers, Inc.600-0032025-09-30
10190707143036Ortho Performance®Ortho Organizers, Inc.600-0052025-09-30
10190707143043Ortho Performance®Ortho Organizers, Inc.600-0062025-09-30
10190707143050Ortho Performance®Ortho Organizers, Inc.600-0072025-09-30
10190707143067Ortho Performance®Ortho Organizers, Inc.600-0082025-09-30
10190707143074Ortho Performance®Ortho Organizers, Inc.600-0092025-09-30
10190707143081Ortho Performance®Ortho Organizers, Inc.600-0102025-09-30
10190707143098Ortho Performance®Ortho Organizers, Inc.600-0132025-09-30
10190707149045Comfort Cover™Ortho Organizers, Inc.981652025-10-01
10190707192966Ortho Technology®Ortho Organizers, Inc.98165D2025-10-23
10190707193215Orthosil™Ortho Organizers, Inc.600-0502025-10-23
06978785665070InhwRiorShenzhen Yuechuan trade Co., Ltd.ZJNJ2025-12-08
00840456207604JMUJMU DENTAL, INC514040062025-07-15
00840456207611JMUJMU DENTAL, INC514040072025-07-15
00840456207628JMUJMU DENTAL, INC514040082025-07-15
00840456207635JMUJMU DENTAL, INC514040092025-07-15
00840456207642JMUJMU DENTAL, INC514040102025-07-15
00190886135498NAG & H Wire Company, Inc.EB-252025-03-31
00190886135559NAG & H Wire Company, Inc.700-1112025-03-31
00190886135672NAG & H Wire Company, Inc.EB-25G2025-03-31
00190886135689NAG & H Wire Company, Inc.EB-25PBG2025-03-31
00190886140690NAG & H Wire Company, Inc.M350-022025-03-31
00190886154086NAG & H Wire Company, Inc.UWX11642025-03-31
10190886135648NAG & H Wire Company, Inc.BWX0212025-03-31
20190886135638NAG & H Wire Company, Inc.700-0992025-03-31
20190886135652NAG & H Wire Company, Inc.PWX5362025-03-31
20190886135669NAG & H Wire Company, Inc.PWX6362025-03-31
20190886154172NAG & H Wire Company, Inc.PWX5372025-03-31
J011119150000N.A.DENTAURUM GmbH & Co.KG119-150-002016-09-15
J011124002000Flexaponal®DENTAURUM GmbH & Co.KG124-002-002016-09-15
J011124003000Flexaponal®DENTAURUM GmbH & Co.KG124-003-002016-09-15