FDA.reportPublic FDA data

Dental cheek retractor, professional, single-use

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 single-use device.
GUDID devices
85
Last updated
2026-07-17 21:59:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840456223321JMUJMU DENTAL, INC442070022026-07-07
00840456223352JMUJMU DENTAL, INC442070052026-07-07
00840456200186JMUJMU DENTAL, INC101070072026-07-06
00840326404898The Orthodontic StoreYoung Innovations, Inc.615-5002022-11-02
00840326404928The Orthodontic StoreYoung Innovations, Inc.615-5502022-11-02
00843471144756Young SpecialtiesYoung Innovations, Inc.615-0752022-11-24
00843471144787The Orthodontic StoreYoung Innovations, Inc.615-4002022-11-02
00843471144794The Orthodontic StoreYoung Innovations, Inc.615-4502022-11-02
00857848007216BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)Beyond International Inc.BY-PD01205M2022-12-23
00857848007223BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)Beyond International Inc.BY-PD01205L2022-12-23
00857848007292BEYOND® II Cheek Retractor (5 pack)Beyond International Inc.BY-M0122022-12-23
00857848007599BEYOND® FlexiPro™ Cheek Retractor (5 pack)-LBeyond International Inc.BY-M015-L2022-12-23
00857848007605BEYOND® FlexiPro™ Cheek Retractor (single pack)-LBeyond International Inc.BY-M016-L2022-12-23
00857848007681BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MBeyond International Inc.BY-M015-M2022-12-23
00857848007698BEYOND® FlexiPro™ Cheek Retractor (single pack)-MBeyond International Inc.BY-M016-M2022-12-23
00857848007704BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MixedBeyond International Inc.BY-M015-MIX2022-12-23
07615208473940GBT VisigateIVOCLAR VIVADENT AKTIENGESELLSCHAFT7602332023-09-25
07615208474152GBT VisigateIVOCLAR VIVADENT AKTIENGESELLSCHAFT7602342023-09-25
07615208474169GBT VisigateIVOCLAR VIVADENT AKTIENGESELLSCHAFT7602352023-09-25
07615208474176GBT VisigateIVOCLAR VIVADENT AKTIENGESELLSCHAFT7602562023-09-25
07615208474183GBT VisigateIVOCLAR VIVADENT AKTIENGESELLSCHAFT7602572023-09-25
07615208484076OptraGateIVOCLAR VIVADENT AKTIENGESELLSCHAFT762773WW2024-09-11
07615208513660OptraGate 2IVOCLAR VIVADENT AKTIENGESELLSCHAFT762098WW2024-11-19
07615208516982OptraGate 2IVOCLAR VIVADENT AKTIENGESELLSCHAFT757915WW2025-02-21
07630716603658Geistlich PanoramaDSSM AG7695322025-09-17
07630716603665Geistlich PanoramaDSSM AG7695332025-09-17
07630716603672Geistlich PanoramaDSSM AG7695342025-09-17
07630716603689Geistlich PanoramaDSSM AG7695352025-09-17
10304040196998Henry ScheinHENRY SCHEIN, INC.57058662026-05-14
10304040197001Henry ScheinHENRY SCHEIN, INC.57058672026-05-14
10304040197018Henry ScheinHENRY SCHEIN, INC.57058682026-05-14
D832EX9006L1EXTNDPLASDENT CORPORATIONEX-9006-L2022-02-01
D832EX9007M1EXTNDPLASDENT CORPORATIONEX-9007-M2022-02-01
D832EX9008S1EXTNDPLASDENT CORPORATIONEX-9008-S2022-02-01
D832MURM1PlasdentPLASDENT CORPORATIONMUR-M2025-06-24
D832MURS1PlasdentPLASDENT CORPORATIONMUR-S2025-06-24
DVIV577275WW1OptraGate AssortmentIVOCLAR VIVADENT AKTIENGESELLSCHAFT577275WW2021-04-09
DVIV590850WW1OPTRAGATEIVOCLAR VIVADENT AKTIENGESELLSCHAFT590850WW2021-04-09
DVIV590851WW1OPTRAGATEIVOCLAR VIVADENT AKTIENGESELLSCHAFT590851WW2021-04-09
DVIV591451WW1OPTRAGATEIVOCLAR VIVADENT AKTIENGESELLSCHAFT591451WW2021-04-09
DVIV669088WW1OptraGate Small Assort.blue pinkIVOCLAR VIVADENT AKTIENGESELLSCHAFT669088WW2021-04-09
DVIV669089WW1OptraGate Junior Assort. blue pinkIVOCLAR VIVADENT AKTIENGESELLSCHAFT669089WW2021-04-09
DVIV695568WW1OptraGate Test PackIVOCLAR VIVADENT AKTIENGESELLSCHAFT695568WW2021-04-09
DVIV757912WW1OptraGate 2IVOCLAR VIVADENT AKTIENGESELLSCHAFT757912WW2024-11-19
DVIV757914WW1OptraGate 2IVOCLAR VIVADENT AKTIENGESELLSCHAFT757914WW2024-11-19
00810042124844OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCX009-0062025-11-26
00810042124851OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCX009-0072025-11-26
00810042124868OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCX009-0082025-11-26
07630716616382Geistlich PanoramaDSSM AG7695332025-09-17
07630716616399Geistlich PanoramaDSSM AG7695342025-09-17
07630716617037Geistlich PanoramaDSSM AG7695322025-09-17
07630716617051Geistlich PanoramaDSSM AG7695352025-09-17
07615208535907OptraGate 2IVOCLAR VIVADENT AKTIENGESELLSCHAFT757915WW2025-02-21
00883205032485Ultradent Cheek RetractorULTRADENT PRODUCTS, INC.48702024-12-17
00883205032492Ultradent Cheek RetractorULTRADENT PRODUCTS, INC.48712024-12-17
00810059291461Denovo Clearfield cheek retractorsDenovo Dental, Inc.430-3002023-06-30
00810059291478Denovo Clearfield cheek retractorsDenovo Dental, Inc.430-400 2023-06-30
10843471144753The Orthodontic StoreYoung Innovations, Inc.615-0752022-11-24
B9745039860Cheek RetractorDR.FRIGZ INTERNATIONAL(PVT)LTD,Minnesota Cheek Retractor2022-11-21
10840326404895The Orthodontic StoreYoung Innovations, Inc.615-5002022-11-02
10840326404925The Orthodontic StoreYoung Innovations, Inc.615-5502022-11-02
10843471144784The Orthodontic StoreYoung Innovations, Inc.615-4002022-11-02
10843471144791The Orthodontic StoreYoung Innovations, Inc.615-4502022-11-02
D832EX9006L0EXTNDPLASDENT CORPORATIONEX-9006-L2022-02-01
D832EX9007M0EXTNDPLASDENT CORPORATIONEX-9007-M2022-02-01
D832EX9008S0EXTNDPLASDENT CORPORATIONEX-9008-S2022-02-01
00850362007113KöREVOLVE DENTAL TECHNOLOGIES, INC.KöR Retractor & Suction Tip (Max)2021-03-31
00850362007120KöREVOLVE DENTAL TECHNOLOGIES, INC.KöR Retractor & Suction Tip (Ulra)2021-03-31
00850362007151KöREVOLVE DENTAL TECHNOLOGIES, INC.KöR Retractor (Blue) - Medium2021-03-31
00850362007168KöREVOLVE DENTAL TECHNOLOGIES, INC.KöR Retractor (Green) - Small2021-03-31
00850362007175KöREVOLVE DENTAL TECHNOLOGIES, INC.KöR Retractor (Red) - Large2021-03-31
08710103632085Philips Zoom! WhiteSpeed IsoPrep RetractorDiscus Dental, LLCDIS5732020-08-28
08710103632092Philips Zoom! IsoPrep RetractorDiscus Dental, LLCDIS5742020-08-28
00883205030696Ultradent Cheek RetractorULTRADENT PRODUCTS, INC.48702019-07-19
00883205030702Ultradent Cheek RetractorULTRADENT PRODUCTS, INC.48712019-07-19
00883205030719Ultradent Cheek RetractorULTRADENT PRODUCTS, INC.48722019-07-19
00190730032942Intraoral Cheek RetractorsORTHO TECHNOLOGY, INC.601-2202019-05-15
00190730032959Intraoral Cheek RetractorsORTHO TECHNOLOGY, INC.601-2212019-05-15
00190730032966Intraoral Cheek RetractorsORTHO TECHNOLOGY, INC.601-2222019-05-15
00190730032973Extraoral Cheek RetractorsORTHO TECHNOLOGY, INC.601-2302019-05-15