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Device Explorer · FDA GUDID · GMDN 31849

Rubber dam frame

A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusab

US‑registered devices52in commercial distribution
Companies23labelers on GUDID
Single‑use0%of device records
Sterile2%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Coltene/Whaledent Inc1121%
Young Dental Manufacturing I, Llc510%
Dent4You Ag510%
Hu-Friedy Mfg. Co., Llc48%
Densol International (Private) Limited36%
Dentech Corporation24%
Devemed Gmbh24%
Plasdent Corporation24%

Top labelers

CompanyDevicesShare
Coltene/Whaledent Inc1121%
Young Dental Manufacturing I, Llc510%
Dent4You Ag510%
Hu-Friedy Mfg. Co., Llc48%
Densol International (Private) Limited36%
Dentech Corporation24%
Devemed Gmbh24%
Plasdent Corporation24%
Benco Dental Supply Co.24%
American Medicals24%
Osung Mnd Co., Ltd.24%
Kohler Medizintechnik Gmbh12%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DENTECHKOHDENTReicodentPremium PlusPlasdentPDT, Inc.House Brand DentistryStarDental Instrument SolutionsDam FrameHYGENICHygenicBurkhart Dental SupplyBENCOHenry ScheinYoungAmerican Medicals

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

FDA product codes

CodeNameDevices
EJEFrame, Rubber Dam33
EJEFRAME, RUBBER DAM10
NRDUnit, Operative Dental, Accessories3
EIEDam, Rubber2
MDMInstrument, Manual, Surgical, General Use2
EEFCLAMP, RUBBER DAM1

GMDN & GCC registration

  • GMDN code 31849 · non‑implantable
  • Single‑use 0% · sterile 2% · Rx‑only 52% · 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 rubber dam frame products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rubber dam frame", from 23 companies. The largest labeler is Coltene/Whaledent Inc with 21% of records.

Which FDA product codes apply?

EJE (Frame, Rubber Dam), EJE (FRAME, RUBBER DAM), NRD (Unit, Operative Dental, Accessories), EIE (Dam, Rubber)

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.

How do I get quotes?

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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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