Consulting Wallah › Device Explorer › Other devices › Rubber dam, non-latex
Device Explorer · FDA GUDID · GMDN 45004

Rubber dam, non-latex

A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to e

US‑registered devices178in commercial distribution
Companies36labelers on GUDID
Single‑use77%of device records
Sterile2%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Four D Rubber Company Limited3419%
Ultradent Products, Inc.2011%
Beijing C-Root Dental Medical Devices Co., Ltd.148%
Dent4You Ag137%
Clinician'S Choice Dental Products, Inc.106%
Mavrik Dental System Inc.84%
Darby Dental Supply, Llc84%
Safco Dental Supply Co.84%

Top labelers

CompanyDevicesShare
Four D Rubber Company Limited3419%
Ultradent Products, Inc.2011%
Beijing C-Root Dental Medical Devices Co., Ltd.148%
Dent4You Ag137%
Clinician'S Choice Dental Products, Inc.106%
Mavrik Dental System Inc.84%
Darby Dental Supply, Llc84%
Safco Dental Supply Co.84%
Zirc Dental Products, Inc.74%
Den-Mat Holdings, Llc63%
Ascend Eagle Incorporated53%
Peter Brasseler Holdings, Llc42%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EdgeDam™ Sample Heavy 6x6 Latex-FreeEdgeDam™ Refill Medium 5x5 Latex-FreeEdgeDam™ Refill Medium 6x6 Latex-FreeEdgeDam™ Refill Heavy 5x5 Latex-FreeEdgeDam™ Refill Heavy 6x6 Latex-FreeTrue™ Dental Dam Latex Free 6x6 Heavy SampleTrue™ Dental Dam Latex Free 6x6 Heavy GaugeTrue™ Dental Dam Latex Free 5x5 Heavy GaugeTrue™ Dental Dam Latex Free 6x6True™ Dental Dam Latex Free 5x5Nic Tone, MDC DentalPRO-OPTIONSMavrik Dental SystemC-RootISODAMUltradent

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

FDA product codes

CodeNameDevices
EIEDam, Rubber111
EIEDAM, RUBBER61
EIGRETRACTOR, ALL TYPES12
EIGRetractor, All Types3
EJEFRAME, RUBBER DAM3
EIFACCESSORIES, RETRACTOR, DENTAL2

GMDN & GCC registration

  • GMDN code 45004 · non‑implantable
  • Single‑use 77% · sterile 2% · Rx‑only 67% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Area/Surface Area (Square inch) · 21Length (Millimeter) · 7Width (Millimeter) · 7Height (Millimeter) · 7Total Volume (Milliliter) · 2

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

How many rubber dam, non-latex products are registered in the US?

178 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rubber dam, non-latex", from 36 companies. The largest labeler is Four D Rubber Company Limited with 19% of records.

Which FDA product codes apply?

EIE (Dam, Rubber), EIE (DAM, RUBBER), EIG (RETRACTOR, ALL TYPES), EIG (Retractor, All Types)

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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