Consulting Wallah › Device Explorer › Other devices › Rubber dam, Hevea-latex
Device Explorer · FDA GUDID · GMDN 11155

Rubber dam, Hevea-latex

A sheet of elastomeric material made of Hevea natural rubber latex (NRL) 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 c

US‑registered devices274in commercial distribution
Companies24labelers on GUDID
Single‑use98%of device records
Sterile2%labelled sterile
Prescription55%Rx‑only share
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Share of device records

Coltene/Whaledent Inc5420%
Dent4You Ag3714%
Mdc Dental228%
Darby Dental Supply, Llc207%
Four D Rubber Company Limited197%
Crosstex International, Inc.187%
Benco Dental Supply Co.166%
Safco Dental Supply Co.124%

Top labelers

CompanyDevicesShare
Coltene/Whaledent Inc5420%
Dent4You Ag3714%
Mdc Dental228%
Darby Dental Supply, Llc207%
Four D Rubber Company Limited197%
Crosstex International, Inc.187%
Benco Dental Supply Co.166%
Safco Dental Supply Co.124%
Amd Medicom Inc124%
Clinician'S Choice Dental Products, Inc.104%
Mexpo International Inc.104%
Ascend Eagle Incorporated83%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EdgeDam™ Sample Medium 6x6 LatexEdgeDam™ Refill Medium 5x5 LatexEdgeDam™ Refill Medium 6x6 LatexEdgeDam™ Refill Heavy 5x5 LatexEdgeDam™ Refill Heavy 6x6 LatexTrue™ Dental Dam Latex 6x6 Sample PackTrue™ Dental Dam Latex 6x6 Heavy GaugeTrue™ Dental Dam Latex 5x5 Heavy GaugeTrue™ Dental Dam Latex 5x5True™ Dental Dam Latex 6x6Nic Tone, MDC DentalEasy Dam, MDC DentalNIC TONE, MDC DentalPRO-OPTIONSUltradentBIODAM

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

FDA product codes

CodeNameDevices
EIEDam, Rubber195
EIEDAM, RUBBER107
EJEFrame, Rubber Dam21
EEFClamp, Rubber Dam1

GMDN & GCC registration

  • GMDN code 11155 · non‑implantable
  • Single‑use 98% · sterile 2% · Rx‑only 55% · OTC 4%
  • 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) · 20

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

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

274 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rubber dam, Hevea-latex", from 24 companies. The largest labeler is Coltene/Whaledent Inc with 20% of records.

Which FDA product codes apply?

EIE (Dam, Rubber), EIE (DAM, RUBBER), EJE (Frame, Rubber Dam), EEF (Clamp, Rubber Dam)

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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