Dental Mouth Prop: What It Is and How FDA Files It

General product information only, not medical or clinical advice. This page does not describe how to use a mouth prop on a patient.

Short answer

A dental mouth prop is a small device placed between the upper and lower teeth to keep the mouth open. FDA has no product code named “mouth prop”: the same name is filed under several codes, all class I, so the product’s own record shows what an item is.

Definition and scope

FDA’s Global Unique Device Identification Database (GUDID) holds a manufacturer-written description for many devices sold as mouth props. One such record, for a reusable device filed under product code BRW, reads: “A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop.”

That record shows two things worth knowing. First, one device can carry several names. Second, a mouth prop is described by what it holds open (the jaws), not by a single clinical specialty. Other devices that also hold the mouth or airway area open are covered on separate pages: the bite block used with endoscopes, the ENT mouth gag, and the saliva ejector, which manages fluid rather than jaw position.

How a mouth prop is described in FDA and manufacturer records

Record fields are the most reliable description of what a specific product is. In GUDID and openFDA device data (checked 2026-10-31), items listed as mouth props show these recurring attributes:

• Sizes: listings use words such as small child, child or pediatric, medium, adult and large rather than one numeric standard.
• Materials: listings name silicone, rubber, plastic and plastic-coated metal frames.
• Reuse status: some records flag single use, others describe the device as reusable.
• Packaging: some are listed individually, others in pairs or boxes of two.

Records can disagree with themselves. One disposable-labeled mouth prop record carries a single-use flag but its GMDN text says “reusable”, so neither field should be treated as settled without the manufacturer’s instructions for use.

Types and how FDA files them

The table below is the information this page adds beyond product listings. It shows the FDA product codes under which the phrase “mouth prop” or a close synonym appears in GUDID, with each code’s classification record from openFDA (checked 2026-10-31).

FDA product code	FDA device name	Regulation	Class
BRW	Protector, Dental	21 CFR 868.5820	I
EIG	Retractor, All Types	21 CFR 872.4565	I
LXH	Orthopedic Manual Surgical Instrument	21 CFR 888.4540	I
KBN	Gag, Mouth	21 CFR 874.4420	I
LRC	Instrument, ENT Manual Surgical	21 CFR 874.4420	I
MNK	Endoscopic Bite Block	21 CFR 876.1500	I

The openFDA classification database has no entry whose device name is “mouth prop”. Code BRW is the dental protector, which 21 CFR 868.5820 defines as “a device intended to protect a patient’s teeth during manipulative procedures within a patient’s oral cavity.” Code EIG falls under 21 CFR 872.4565, the dental hand instrument regulation, for hand-held devices used in general dentistry and oral surgery. Code KBN covers the mouth gag; 21 CFR 874.4420 lists a mouth gag and an oral screw among ENT manual surgical instruments.

Where it matters for labs, clinics and supply decisions

For anyone cataloguing or ordering these items, the cross-walk above has one practical consequence: the same product name maps to different regulatory descriptions, so a code alone does not tell you what a product is. These fields, visible in AccessGUDID for each product, are worth checking:

1. Single-use or reusable, as flagged in the record and as stated in the manufacturer’s instructions for use.
2. Labeling about natural rubber latex, which some records state explicitly.
3. Size wording (child, adult and so on) and the material named.
4. Whether the record describes the device as a mouth prop, a bite block or a jaw spreader, since all three terms appear.

Where two fields conflict, the manufacturer’s instructions for use take precedence for that product. For hospital-style airway and endoscopy settings, see the bite block page; for related ENT and dental hand instruments, see ENT surgical instruments and what is a surgical retractor.

Common misunderstandings

• “There is an FDA category for mouth props.” There is not; the term is a trade name that spans several product codes.
• “A mouth prop and a bite block are the same product.” The words overlap in some records, but the endoscopic bite block has its own code (MNK) and regulation, and the two are not interchangeable by name alone.
• “Class I means no oversight.” Class I devices are subject to general controls; the dental protector regulation also makes the device exempt from premarket notification (510(k)) subject to the limitations in 21 CFR 868.9.

FAQ

What is a mouth prop used for?

It is intended to hold the jaws apart so the mouth stays open. FDA’s database wording for one such device gives its purpose as maintaining an open oral cavity, for example for an oral surgical intervention or during emergent placement of an artificial airway.

Is a mouth prop the same as a bite block?

Not always. Some GUDID records use both names for one item, but FDA classifies an endoscopic bite block separately (product code MNK, 21 CFR 876.1500). Read the product record rather than relying on the name.

How does FDA classify a mouth prop?

There is no dedicated classification. Products sold as mouth props are filed under several class I product codes, including BRW (dental protector), EIG (retractor), KBN (mouth gag) and LXH (orthopedic manual surgical instrument).

Sources

• openFDA device classification API, product codes BRW, EIG, LXH, KBN, LRC, MNK: api.fda.gov/device/classification.json (checked 2026-10-31).
• openFDA device UDI data and AccessGUDID device records: accessgudid.nlm.nih.gov (checked 2026-10-31).
• 21 CFR 868.5820, Dental protector: law.cornell.edu (checked 2026-10-31).
• 21 CFR 872.4565, Dental hand instrument: law.cornell.edu (checked 2026-10-31).
• 21 CFR 874.4420, Ear, nose, and throat manual surgical instrument: law.cornell.edu (checked 2026-10-31).