Consulting Wallah › Device Explorer › Dental › Dental cheek retractor, professional, single-use
Device Explorer · FDA GUDID · GMDN 63315

Dental cheek retractor, professional, single-use

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 li

US‑registered devices72in commercial distribution
Companies16labelers on GUDID
Single‑use93%of device records
Sterile0%labelled sterile
Prescription61%Rx‑only share
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Share of device records

Ivoclar Vivadent Aktiengesellschaft1724%
Beyond International Inc.811%
Ultradent Products, Inc.57%
Plasdent Corporation57%
Evolve Dental Technologies, Inc.57%
Young Innovations, Inc.57%
Ortho Technology, Inc.46%
Dssm Ag46%

Top labelers

CompanyDevicesShare
Ivoclar Vivadent Aktiengesellschaft1724%
Beyond International Inc.811%
Ultradent Products, Inc.57%
Plasdent Corporation57%
Evolve Dental Technologies, Inc.57%
Young Innovations, Inc.57%
Ortho Technology, Inc.46%
Dssm Ag46%
North Eos Industries Inc.34%
Jmu Dental, Inc34%
Orthodontic Supply & Equipment Company Inc34%
Henry Schein, Inc.34%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EOSOptraGate 2OptraGate Test PackOptraGate Junior Assort. blue pinkOptraGate Small Assort.blue pinkOPTRAGATEOptraGate AssortmentUltradent Cheek RetractorBEYOND® FlexiPro™ Cheek Retractor (5 pack)-MixedBEYOND® FlexiPro™ Cheek Retractor (single pack)-BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MBEYOND® FlexiPro™ Cheek Retractor (single pack)-BEYOND® FlexiPro™ Cheek Retractor (5 pack)-LBEYOND® II Cheek Retractor (5 pack)BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pPlasdent

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EIFACCESSORIES, RETRACTOR, DENTAL27
EIGRetractor, All Types22
EIGRETRACTOR, ALL TYPES13
BRWProtector, Dental5
EIFAccessories, Retractor, Dental3
DYNMouthpiece, Saliva Ejector2

GMDN & GCC registration

  • GMDN code 63315 · non‑implantable
  • Single‑use 93% · sterile 0% · Rx‑only 61% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many dental cheek retractor, professional, single-use products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental cheek retractor, professional, single-use", from 16 companies. The largest labeler is Ivoclar Vivadent Aktiengesellschaft with 24% of records.

Which FDA product codes apply?

EIF (ACCESSORIES, RETRACTOR, DENTAL), EIG (Retractor, All Types), EIG (RETRACTOR, ALL TYPES), BRW (Protector, Dental)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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