FDA.reportPublic FDA data

Dental cheek retractor, professional, reusable

Definition
A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.
GUDID devices
488
Last updated
2026-07-15 00:47:55

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850083275570Intrace USAPILOTIS TECH LLCANE-04-0382026-07-03
D2486054630Spandex Advanced Junior/Small (Black)HAGER WORLDWIDE, INC.6054632026-06-07
D2486054640Spandex Advanced Standard/Med (Pink)HAGER WORLDWIDE, INC.6054642026-06-07
D2486054651Spandex Advanced - 3 Size Combo Kit- Black (1 Junior/Sm, 1 Standard/Med, 1 LargeHAGER WORLDWIDE, INC.6054652026-06-07
D2486054661Spandex Advanced - 3 Size Combo Kit- Pink (1 Junior/Sm, 1 Standard/Med, 1 Large)HAGER WORLDWIDE, INC.6054662026-06-07
00014081052124Lip-ExHAGER WORLDWIDE, INC.6052122023-07-13
00014081054500Mirahold AdultHAGER WORLDWIDE, INC.6054502023-07-13
00190707103224MaselOrtho Organizers, Inc.4001-0182023-06-08
00190707103231MaselOrtho Organizers, Inc.4001-0192023-06-08
00190707148959Ortho Technology®Ortho Organizers, Inc.ORT-300-0202025-10-01
00190707191153Ortho Technology®Ortho Organizers, Inc.ORT-300-0212025-10-23
00190707191160Ortho Technology®Ortho Organizers, Inc.ORT-300-0222025-10-23
00348783010220Premier RetractorsPREMIER DENTAL PRODUCTS COMPANY10038372026-05-06
00810042120440DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCMUA1-9002020-04-21
00810042120457DENALIORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCMUA2-0002020-04-21
00841685101718A. Titan InstrumentsA. TITAN INSTRUMENTS, INC.039.022023-01-24
00841685101787A. Titan InstrumentsA. TITAN INSTRUMENTS, INC.039.032023-01-24
00841685104221A. Titan InstrumentsA. TITAN INSTRUMENTS, INC.Ronnau2023-01-24
00841685104863A. Titan InstrumentsA. TITAN INSTRUMENTS, INC.Oringer #22023-01-17
00841685104900A. Titan InstrumentsA. TITAN INSTRUMENTS, INC.Oringer #12023-01-17
00843471144800Young SpecialtiesYoung Innovations, Inc.615-6002022-11-02
00843471144831Young SpecialtiesYoung Innovations, Inc.615-7002022-11-02
00843471144848Young SpecialtiesYoung Innovations, Inc.615-8002022-11-01
00843471144879Young SpecialtiesYoung Innovations, Inc.615-9002022-11-02
00843471144886Young SpecialtiesYoung Innovations, Inc.615-9502022-11-02
00852253006380Free Access II Cheek Retractor LargeJ. MORITA U.S.A., INC21303100L2023-07-13
00852253006397Free Access II Cheek Retractor SmallJ. MORITA U.S.A., INC21303100S2023-07-13
00860009140608Retractor, All Types, Retract Eez Inc.MFR #140722022-12-31
03760405340121ScanBox pro Smile DoctorsDENTAL MONITORING0012025-02-14
03760405340145ScanBox pro Smile doctorsDENTAL MONITORING0012025-02-14
03760405340169ScanBox pro - Candid DENTAL MONITORING0012025-02-14
03760405340206ScanBox pro DENTAL MONITORING0012025-02-14
03770021392077ScanBox proDENTAL MONITORING0012022-11-01
03770021392138ScanBox pro - Smile DoctorsDENTAL MONITORING0012022-11-01
03770021392145Scanbox pro - Smile DoctorsDENTAL MONITORING0012022-11-01
03770021392176ScanBox pro - CandidDENTAL MONITORING0012022-11-01
03770021392237DM Cheek RetractorDENTAL MONITORING0012022-11-01
03770021392244DM Cheek RetractorDENTAL MONITORING0012022-11-01
03770021392251DM Cheek RetractorDENTAL MONITORING0012022-11-01
03770021392336DM ScanBoxDENTAL MONITORING0012022-11-01
03770021392404 ScanBox pro DENTAL MONITORING0012022-11-01
03770021392435ScanBox pro DENTAL MONITORING0012022-11-01
03770021392794ScanBox proDENTAL MONITORING0012024-09-16
03770021392800ScanBox pro DENTAL MONITORING0012024-09-16
03770021392824ScanBox pro DENTAL MONITORING0012024-09-16
03770021392879ScanBox pro - Smile DoctorsDENTAL MONITORING0012024-09-16
03770021392886ScanBox pro - Smile DoctorsDENTAL MONITORING0012024-09-16
03770021392916ScanBox pro - CandidDENTAL MONITORING0012024-09-16
10304040114350Henry ScheinHENRY SCHEIN, INC.10634572019-07-25
10304040114367Henry ScheinHENRY SCHEIN, INC.10651182019-07-25
10304040114398Henry ScheinHENRY SCHEIN, INC.10670782019-07-25
10304040114404Henry ScheinHENRY SCHEIN, INC.10670792019-07-25
10889950013271HU-FRIEDYHU-FRIEDY MFG. CO., LLCGRK12020-11-12
10889950101213HU-FRIEDYHU-FRIEDY MFG. CO., LLCXP51072020-11-12
14026704802910PILLINGTELEFLEX INCORPORATEDIPN0207442022-12-08
14026704802927PILLINGTELEFLEX INCORPORATEDIPN0207452022-12-08
14026704802934PILLINGTELEFLEX INCORPORATEDIPN0207462022-12-08
14026704803160PILLINGTELEFLEX INCORPORATEDIPN0207872022-12-08
14026704808547PILLINGTELEFLEX INCORPORATEDIPN0216322022-12-08
14026704808578PILLINGTELEFLEX INCORPORATEDIPN0216362022-12-08
14026704808653PILLINGTELEFLEX INCORPORATEDIPN0216522022-12-08
D2486052101Bite BlockHAGER WORLDWIDE, INC.6052102023-07-13
D2486052111Bite BlockHAGER WORLDWIDE, INC.6052112023-07-13
D2486054501Mirahold AdultHAGER WORLDWIDE, INC.6054502024-02-05
D2486054511Mirahold ChildHAGER WORLDWIDE, INC.6054512024-07-03
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.6054612025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.6054622025-10-22
D832EX90001EXTNDPLASDENT CORPORATIONEX-90002022-02-01
D832EX90011EXTNDPLASDENT CORPORATIONEX-90012022-02-01
D832EX9001T1EXTNDPLASDENT CORPORATIONEX-9001T2022-02-01
D832EX90021EXTNDPLASDENT CORPORATIONEX-90022022-02-01
D832EX90031EXTNDPLASDENT CORPORATIONEX-90032022-02-01
D832EX90041EXTNDPLASDENT CORPORATIONEX-90042022-02-01
D832EX90051EXTNDPLASDENT CORPORATIONEX-90052022-02-01
D832EX90061EXTNDPLASDENT CORPORATIONEX-90062022-02-01
D832EX90071EXTNDPLASDENT CORPORATIONEX-90072022-02-01
D832EX90081EXTNDPLASDENT CORPORATIONEX-90082022-02-01
D832EX90101EXTNDPLASDENT CORPORATIONEX-90102022-02-01
D832EX90201EXTNDPLASDENT CORPORATIONEX-90202022-02-01
D9281055201RETRACTOR U.S. ARMY (SET/2)W.H. Holden, Inc.10-55202023-11-01