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General product information only, not medical or dental advice. This page does not describe how to place or use a rubber dam in a patient.
Short answer
A rubber dam is a thin sheet of latex with a hole in the centre, used in dentistry to isolate a tooth from fluids in the mouth during dental procedures. In the United States, the FDA regulation that covers it, 21 CFR 872.6300, defines the device as the dam together with a clamp, a frame and clamp forceps, and classifies all of it as Class I (general controls), exempt from premarket notification.
Definition and scope
The wording comes from 21 CFR 872.6300, “Rubber dam and accessories”. It describes a device “composed of a thin sheet of latex with a hole in the center” that is stretched around a tooth by inserting the tooth through the hole, and it names filling a cavity preparation as an example of the procedures involved. The regulation says the device includes “the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp”.
The regulation draws one boundary. It excludes devices intended to prevent transmission of sexually transmitted diseases through oral sex, which are classified as condoms under 21 CFR 884.5300. A product sold for that purpose is therefore not a “rubber dam and accessories” device in the dental sense, even if people call both a “dental dam”.
The four components named in the regulation
The FDA product-code database lists one code for each component named in the regulation, all under regulation number 872.6300 and all Class 1.
| Component | FDA device name | Product code | Class |
|---|---|---|---|
| Sheet (the dam) | Dam, Rubber | EIE | 1 |
| Clamp | Clamp, Rubber Dam | EEF | 1 |
| Frame | Frame, Rubber Dam | EJE | 1 |
| Clamp forceps | Forceps, Rubber Dam Clamp | EJG | 1 |
The product code is the identifier that regulators and catalogues use to group like devices, so it is a practical lookup key when a supplier lists a clamp or a frame without naming the regulation.
How it is classified
Under 21 CFR 872.6300(b) the device is Class I (general controls). It is exempt from the premarket notification (510(k)) procedures in subpart E of part 807, subject to 21 CFR 872.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the quality management system requirements in part 820, except the requirements for records and complaint files under 820.35.
A 510(k) record for a rubber dam clamp does exist from before the exemption was in place: K923163, a “Rubber Dam Clamp” from Aseptico Inc., decided 28 December 1992 as substantially equivalent (product code EIE). For how the device-classification system itself works, see the what is a medical device guide and the Medical Device Amendments of 1976.
Variants you will see in catalogues
Rubber dam material
The regulation describes the sheet as latex. It does not address other sheet materials, so the material of a given product is what its own labeling states. For how thickness and material are specified in a different product category, see nitrile glove thickness (mil) and the glove compatibility chart.
Rubber dam thickness
The regulation sets no thickness requirement or grading scheme. Thickness is a manufacturer specification, so it is stated on the manufacturer’s own labeling rather than in the federal classification.
Rubber dam clamp types and dental dam clamp
“Dental dam clamp” and “rubber dam clamp” are the same component. The FDA lists it as “Clamp, Rubber Dam” (EEF), and the regulation treats it as one device with its own forceps (EJG). The regulation does not divide clamps into classes by shape or tooth position; clamp variants are a manufacturer and catalogue distinction.
Dental dam frame
The frame is the component named “Frame, Rubber Dam” (EJE). Like the clamp, it is a named part of the regulated device.
Dental dam punch
A punch is not named in the regulation text, and none of the four product codes under 872.6300 is a punch. Where a catalogue lists a punch next to a rubber dam kit, the regulation does not tell you how that item is classified.
Rubber dam types and parts
The “parts of a rubber dam” in the federal sense are the four components in the table above. Any further “type” distinctions, such as sheet sizes or kit bundles, come from manufacturers rather than from the regulation.
Where it matters for clinics and supply decisions
- Catalogue lookups. The four product codes (EIE, EEF, EJE, EJG) and regulation number 872.6300 identify the family, which helps when a listing uses different names for the same component.
- Latex labeling. Because the regulation defines the sheet as latex, whether a product is latex or not is a labeling question answered by the manufacturer’s information, not by the classification.
- Sterility claims. The part 820 exemption applies only if the device is not labeled or represented as sterile, so a sterile-labeled item sits under a different manufacturing-controls position than a non-sterile one.
- Sterile labeling. For general background on what sterilization methods and standards involve, see sterilization technology.
Common misunderstandings
“A dental dam and a rubber dam are different devices.”
The regulation covers the dental sheet and its accessories, and its only carve-out is for products intended to prevent transmission of sexually transmitted diseases through oral sex, which are classified as condoms under 21 CFR 884.5300.
“Class I means unregulated.”
Class I devices are still subject to general controls. What this regulation removes is premarket notification and, for non-sterile items, most of the part 820 manufacturing requirements.
“The regulation covers every accessory.”
It names four components. Other items sold with a rubber dam kit are not defined by this regulation.
Frequently asked questions
What is a rubber dam?
Under 21 CFR 872.6300 it is a device composed of a thin sheet of latex with a hole in the center, intended to isolate a tooth from fluids in the mouth during dental procedures. The device includes the rubber dam, rubber dam clamp, rubber dam frame and forceps for a rubber dam clamp.
What are the parts of a rubber dam?
The regulation names four: the dam (sheet), clamp, frame and clamp forceps, listed by FDA as product codes EIE, EEF, EJE and EJG.
How does FDA classify a rubber dam?
Class I (general controls), exempt from premarket notification. Non-sterile items are also exempt from most of part 820, except records and complaint files under 820.35.
Is a dental punch part of the regulated device?
A punch is not named in the regulation and none of the four product codes under 872.6300 is a punch.
Are rubber dam thickness and clamp types set by regulation?
No. The regulation sets no thickness grading and does not divide clamps by shape, so these are manufacturer specifications stated on product labeling.
Sources
Each source below was checked on 2026-10-30.
- 21 CFR 872.6300, Rubber dam and accessories, Legal Information Institute (Cornell): https://www.law.cornell.edu/cfr/text/21/872.6300
- FDA openFDA device classification database, regulation number 872.6300 (product codes EIE, EEF, EJE, EJG): https://api.fda.gov/device/classification.json?search=regulation_number:872.6300
- FDA Total Product Life Cycle, product code EJE: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=EJE
- FDA 510(k) K923163: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K923163
