FDA.reportPublic FDA data

Custom-made mouthguard

Definition
A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.
GUDID devices
119
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00042037799229The Doctor's Medtech Products Inc.79922B2020-07-14
00042037799328The Doctor'sMedtech Products Inc.79932E2020-12-08
00047701000403DentekDenTek Oral Care, Inc.10047701000400A2020-07-14
00047701000410DentekDenTek Oral Care, Inc.100477010004172020-12-08
00047701001516DentekDenTek Oral Care, Inc.00015101203I22020-07-14
00047701001752DentekDenTek Oral Care, Inc.100477010017592022-10-05
00047701002773DentekDenTek Oral Care, Inc.00027701203G2020-07-14
00047701004654DentekDenTek Oral Care, Inc.00046501202A2020-07-14
00050428274996DentekDenTek Oral Care, Inc.00015101203I22020-08-07
00050428373262DentekDenTek Oral Care, Inc.00015101203I22020-08-07
00050428538081DentekDenTek Oral Care, Inc.00046501202A2020-08-07
00860313000827NTI-tss PlusKELLER LABORATORIES, INC.12026-04-21
07392222170504The Doctor'sMedtech Products Inc.70502020-12-08
08711744032548The Doctor'sMedtech Products Inc.10304502020-12-08
D00261D0101iNterra™ iNoffice Nightguard Starter KitDENTSPLY INTERNATIONAL INC.61D0102016-09-21
D00261D0201iNterra™ iNoffice NightguardDENTSPLY INTERNATIONAL INC.61D0202016-09-21
D00261D0301iNterra™ iNoffice NightguardDENTSPLY INTERNATIONAL INC.61D0302016-09-21
D00261D0401iNterra™ iNoffice NightguardDENTSPLY INTERNATIONAL INC.61D0402016-09-21
00860013500733Custom Night GuardGrindGuard Inc.12026-03-05
00860013500740Custom Night GuardGrindGuard Inc.12026-03-05
00860014754609Owl Night GuardOWL DENTAL LAB INC12026-03-05
00860014754616Owl Night GuardOWL DENTAL LAB INC12026-03-05
00860014754623Owl Night GuardOWL DENTAL LAB INC12026-03-05
00860015217721enCore Night GuardENCORE LABORATORY LLCHard2026-03-02
00860015217738enCore Night GuardENCORE LABORATORY LLCSoft2026-03-02
00860015217707enCore Night GuardENCORE LABORATORY LLCHybrid2026-01-08
00692121032055SleepRightSplintek Inc.Secure-Comfort2025-12-17
00692121032062SleepRightSplintek Inc.Ultra-Comfort2025-12-17
00692121032246SleepRightSplintek Inc.Dura-Comfort2025-12-17
00692121035438SleepRightSplintek Inc.Select-Comfort2025-12-17
00860007686627Slow WaveSlow Wave, Inc.BROSA2025-09-24
00860013500702Custom Night GuardGrindGuard Inc.12025-03-17
D00261D01062iNterra™ iNoffice Nightguard Starter KitDENTSPLY INTERNATIONAL INC.61D0102016-09-21
D00261D02062iNterra™ iNoffice NightguardDENTSPLY INTERNATIONAL INC.61D0202016-09-21
D00261D04062iNterra™ iNoffice NightguardDENTSPLY INTERNATIONAL INC.61D0402016-09-21
D00261D03062iNterra™ iNoffice NightguardDENTSPLY INTERNATIONAL INC.61D0302016-09-21
00692121035216SleepRightSplintek Inc.ProRx2023-08-30
10042037101432The Doctor's Medtech Products Inc.79922B2020-07-14
10047701000400DentekMedtech Products Inc.10047701000400A2020-07-14
50047701002778DentekMedtech Products Inc.00027701203G2020-07-14
EPRCD1022006PRO3DURE THERMEO Blank pro3dure medical GmbHclear transparent, height 25 mm2022-12-06
00047701000557DentekDenTek Oral Care, Inc.100477010005542022-10-05
00047701001325DentekDenTek Oral Care, Inc.100477010013222022-10-05
10047701001759DentekMEDTECH PRODUCTS INC.100477010017592022-10-05
D00261D1000iNterra™ iNoffice NightguardDENTSPLY INTERNATIONAL INC.61D1002016-09-21
01111111111116CORiTEC Splint Comfort pro3dure medical GmbHclear transparent, height 16 mm2022-09-02
01111111111123CORiTEC Splint Comfortpro3dure medical GmbHclear transparent, height 20 mm2022-09-02
00366975052728BENCOBENCO DENTAL SUPPLY CO.4130-5122022-08-05
00366975052735BENCOBENCO DENTAL SUPPLY CO.4130-5302022-08-05
00366975052742BENCOBENCO DENTAL SUPPLY CO.4130-5492022-08-05
00366975052759BENCOBENCO DENTAL SUPPLY CO.4130-5582022-08-05
00366975052766BENCOBENCO DENTAL SUPPLY CO.4130-5852022-08-05
00366975052773BENCOBENCO DENTAL SUPPLY CO.4130-5672022-08-05
00366975052780BENCOBENCO DENTAL SUPPLY CO.4130-6382022-08-05
00366975052797BENCOBENCO DENTAL SUPPLY CO.4130-6012022-08-05
00366975052803BENCOBENCO DENTAL SUPPLY CO.4130-6102022-08-05
D776105010SICAT OPTIMOTIONSiCAT GmbH & Co. KG105012022-08-07
EPRCD1010119PRO3DURE THERMEO Powder pro3dure medical GmbH180 g Powder - clear transparent2022-04-13
EPRCD1010120PRO3DURE THERMEO Powder pro3dure medical GmbH340 g Powder - clear transparent2022-04-13
EPRCD1010121PRO3DURE THERMEO Powder pro3dure medical GmbH800 g Powder - clear transparent2022-04-13
EPRCD1010122PRO3DURE THERMEO Liquidpro3dure medical GmbH130 ml Liquid - clear transparent2022-04-13
EPRCD1010123PRO3DURE THERMEO Liquidpro3dure medical GmbH255 ml Liquid - clear transparent2022-04-13
EPRCD1010124PRO3DURE THERMEO Liquidpro3dure medical GmbH600 ml Liquid - clear transparent2022-04-13
EPRCD1010125PRO3DURE THERMEO Blank pro3dure medical GmbHcolor A1, height 20 mm2022-04-13
EPRCD1010126PRO3DURE THERMEO Blank pro3dure medical GmbHcolor A2, height 20 mm2022-04-13
EPRCD1010127PRO3DURE THERMEO Blank pro3dure medical GmbHcolor A3, height 20 mm2022-04-13
EPRCD1022002PRO3DURE THERMEO Blank pro3dure medical GmbHclear transparent, height 16 mm2022-04-13
EPRCD1022003PRO3DURE THERMEO Blank pro3dure medical GmbHclear transparent, height 20 mm2022-04-13
00810002220111mmRNA applianceJOHN'S DENTAL LABORATORY INC30146807942022-02-04
10042037799325The Doctor'sMEDTECH PRODUCTS INC.79932E2020-12-08
10047701000417DentekMEDTECH PRODUCTS INC.100477010004172020-12-08
08711744032579The Doctor'sMEDTECH PRODUCTS INC.10304502020-12-08
27392222170508The Doctor'sMEDTECH PRODUCTS INC.70502020-12-08
00810002220029Vivos MrNAJOHN'S DENTAL LABORATORY INC30146807942020-09-08
30050428269870DentekMEDTECH PRODUCTS INC.00015101203I22020-08-07
30050428373263DentekMEDTECH PRODUCTS INC.00015101203I22020-08-07
30050428538082DentekMEDTECH PRODUCTS INC.00046501202A2020-08-07
30047701004655DentekMEDTECH PRODUCTS INC.00046501202A2020-07-14
40047701001514DentekMEDTECH PRODUCTS INC.00015101203I22020-07-14
D8101180EC11ASTRON 1180ASTRON DENTAL CORPORATION1180EC12016-09-07