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General product information only, not medical advice. Decisions about a patient’s latex allergy belong to the treating clinician.
Short answer
A latex-free dental dam is a rubber dam sheet made from a synthetic elastomer or polyisoprene instead of natural rubber latex. In FDA’s device database it shares product code EIE (“DAM, RUBBER”) with latex dams, so the name alone does not tell you how a product is flagged. Check the label and instructions for use for the stated material and latex statement.
Definition and scope
A dental dam (rubber dam) is a thin sheet placed over the teeth during dental procedures. The federal regulation for the device, 21 CFR 872.6300, describes it as composed of a thin sheet of latex with a hole in the center; our guide to what a rubber dam is and how FDA classifies it covers the regulation, the four named parts and the product codes. This page covers only the narrower question of non-latex sheets.
The Global Medical Device Nomenclature (GMDN) carries a separate term for these products: code 45004, “Rubber dam, non-latex”, defined as a sheet of elastomeric synthetic material (for example silicone) that is punched with holes and placed over the teeth during dental procedures. The definition adds that the device may be used for patients and staff who have an allergy to latex, and that it is single-use. (Source: NLM AccessGUDID records, checked 2026-10-30.)
The word “dam” is also used outside dentistry for other barrier products. 21 CFR 872.6300 states that its classification does not include devices intended to prevent transmission of sexually transmitted diseases through oral sex, which are classified as condoms under 21 CFR 884.5300. This page is limited to the dental device.
How it is used in practice
The GMDN definition lists what the sheet is for: to isolate the field of operation from the rest of the oral cavity, to eliminate saliva, to prevent the patient swallowing liquid or dental material, to protect soft tissue from harmful solutions, and to reduce the risk of infection. The non-latex term lists the same functions as the latex-based concept; the difference is the material and the allergy statement. How a clinician places and uses the dam is a matter for the manufacturer’s instructions and professional training and is outside this page.
Materials seen in the regulatory database
| Material wording | Where it appears | Record |
|---|---|---|
| Elastomeric synthetic material (e.g., silicone) | GMDN term 45004 definition, shown on the AccessGUDID record | Safco DENTA-SAFE Non-Latex Dental Dam, medium, 0.18-0.23 mm thickness, 5 in x 5 in, green, box of 20 |
| Polyisoprene (“Premium Polyisoprene Dental Dam”) | Device description on the AccessGUDID record | Den-Mat EdgeDam Refill Heavy 5×5 Latex-Free; the record shows a commercial distribution end date of September 18, 2026 |
Both records list product code EIE, the same code used for latex dams. The Safco record states the thickness range; the Den-Mat record is marked prescription-use and single-use. Both records were checked on 2026-10-30.
Where it matters for labs, clinics and supply decisions
The two records above show why the product name is a weak signal. Each product is named “latex-free” or “non-latex”, yet in both AccessGUDID records two structured fields read “No”: whether the device is required to be labeled as containing natural rubber latex or dry natural rubber under 21 CFR 801.437, and whether it is labeled “Not made with natural rubber latex”. The name says one thing; the structured labeling flags say nothing either way. The label and instructions for use are the place to see what the manufacturer actually states.
A label-check list drawn from the records
- Material stated. Does the label or instructions name the material (silicone-type elastomer, polyisoprene) rather than only a brand word?
- Latex statement. What does the labeling say about natural rubber latex, and does it match the product name?
- Thickness and size. The Safco record states a thickness range and dimensions (0.18-0.23 mm, 5 in x 5 in); a record that omits them leaves the buyer to read the box.
- Single-use. Both records are flagged single-use.
- Intended-for statement. The GMDN text says the device may be used for patients and staff with a latex allergy; check whether the manufacturer’s labeling says the same.
- Record status. AccessGUDID shows a commercial distribution status and end date, so a listed product may no longer be in distribution.
The same name-versus-label issue appears for other latex-related supplies; see latex allergy gloves, vinyl gloves and the latex gloves size chart.
Common misunderstandings
“Latex-free in the name means the record is flagged latex-free.”
Not in the two AccessGUDID records checked for this page: both carry “No” in the 801.437 latex field and “No” in the “Not made with natural rubber latex” field despite their names.
“A non-latex dam is a different kind of device.”
In the FDA database the two non-latex dams checked here share product code EIE, “DAM, RUBBER”, with latex dams. GMDN does give non-latex dams their own term.
“The regulation describes both.”
21 CFR 872.6300 describes a sheet of latex. Whether a given product is non-latex is a question for its labeling.
FAQ
Is there a dental dam that is latex free?
Yes. GMDN term 45004 covers non-latex rubber dams made of synthetic elastomer such as silicone, and AccessGUDID lists a polyisoprene dam as well.
What are non-latex dental dams made of?
The sources cited here name silicone-type synthetic elastomer (GMDN) and polyisoprene (a manufacturer record).
How do I confirm a dam is latex free?
Read the label and instructions for use; the product name and the structured database flags may not agree.
Sources
- NLM AccessGUDID, Safco DENTA-SAFE Non-Latex Dental Dam, DI 10810063750135, accessgudid.nlm.nih.gov/devices/10810063750135, checked 2026-10-30.
- NLM AccessGUDID, EdgeDam Refill Heavy 5×5 Latex-Free (Den-Mat Holdings), DI 00359883006686, accessgudid.nlm.nih.gov/devices/00359883006686, checked 2026-10-30.
- Electronic Code of Federal Regulations, 21 CFR 872.6300, Rubber dam and accessories, ecfr.gov/current/title-21/chapter-I/subchapter-H/part-872/subpart-G/section-872.6300, checked 2026-10-30.
