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General product and regulatory information only. This page is not medical or dental advice and does not describe clinical technique.
Short answer
A dental wedge is a small single-use dental hand device that sits between two adjacent teeth, typically to give slight separation during placement of a filling material or to steady a matrix band or rubber dam. In FDA data it is a Class I dental hand instrument under 21 CFR 872.4565, although that regulation never uses the word “wedge” (sources checked 2026-10-31).
Definition and scope
The Global Medical Device Nomenclature (GMDN) term “Dental wedge, single-use” (code 45007), as displayed in FDA’s device identification data, defines it as “a small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure.” The same entry says it is “typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam),” may include a removable shield for the neighbouring tooth, and is a single-use device.
This page covers the dental device only. It does not cover how a clinician places or removes one, and it is not a buying recommendation.
Where a wedge sits in a matrix system
A wedge is one part of a larger set of restorative accessories. A 2025 systematic review in Cureus (Kamble et al., PMC12204051, checked 2026-10-31) compared two matrix approaches for Class II composite restorations. It describes the circumferential approach as using a matrix band with a wooden wedge, while the sectional approach uses a separation ring. The review’s conclusion is about the band systems, not wedges: it found the sectional matrix band system superior to the circumferential one in achieving optimal proximal contact.
The review draws no wedge-specific conclusion.
For the neighbouring instruments, see the CASRAI guides to the dental matrix band and the amalgam carrier, and to dental composite resin for the material that Class II restorations commonly use.
How FDA classifies it
Three separate records matter, and they do not say quite the same thing.
- The regulation. 21 CFR 872.4565 (eCFR, checked 2026-10-31) defines a dental hand instrument as “a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures” and lists the devices it includes. The list names an “operative matrix contouring instrument,” a “dental matrix band” and a “matrix retainer.” It does not list a wedge by name. The classification is Class I (general controls); a device made of the same materials used before May 28, 1976 is exempt from premarket notification, subject to the limits in 21 CFR 872.9.
- The matrix contouring product code, EKF. FDA’s product classification database (checked 2026-10-31) names code EKF “Instrument, Contouring, Matrix, Operative,” device class 1, regulation 872.4565, medical specialty dental.
- Actual device records. In the openFDA UDI data (the public AccessGUDID dataset, last updated 2026-10-01, checked 2026-10-31), the 23 records described as “Dental wedge, single-use” all carry product code DZN, “Instruments, Dental Hand,” Class 1, regulation 872.4565. All 23 are flagged single-use and not sterile.
All three point to the same regulation and class, but the product code on a given record is whatever the labeler filed. The wedge records in the UDI data read DZN rather than EKF, so a search by one code alone can miss records filed under the other.
Where it matters for labs, clinics and supply decisions
For staff who build product catalogues, check labelling or reconcile item records, the fields that FDA’s public records actually expose for a wedge are these:
| Field on the record | What the wedge records show | Source |
|---|---|---|
| Device description / GMDN term | “Dental wedge, single-use” (GMDN 45007) | openFDA UDI, checked 2026-10-31 |
| Product code | DZN, “Instruments, Dental Hand” | openFDA UDI, checked 2026-10-31 |
| Regulation number and class | 872.4565, Class 1 | openFDA UDI; 21 CFR 872.4565 |
| Single-use flag | True on all 23 records | openFDA UDI, checked 2026-10-31 |
| Sterile flag | False on all 23 records | openFDA UDI, checked 2026-10-31 |
The sterile and single-use flags are what the labelers submitted for those 23 records; they are not a rule about all wedges. For use instructions on a specific product, the manufacturer’s instructions for use are the authority. For the identifier fields themselves, see the CASRAI explainer on the UDI production identifier.
Common misunderstandings
“Wedge” means one device
The word is shared across unrelated devices. FDA’s records separate them clearly.
| Term | What the record says | Source |
|---|---|---|
| Dental wedge, single-use | Dental device placed between adjacent teeth; Class 1 hand instrument, 21 CFR 872.4565 | GMDN 45007 via openFDA UDI; eCFR |
| Bone wedge | Product code PLF, Class 2, regulation 888.3030 | openFDA device classification, checked 2026-10-31 |
| Knee arthroplasty wedge | “An implantable device” used as a space-filler next to a knee prosthesis (GMDN 48067) | openFDA UDI, checked 2026-10-31 |
| X-ray/radiation therapy beam filter, wedge | A wedge-shaped metal filter placed in a radiation beam (GMDN 37692) | openFDA UDI, checked 2026-10-31 |
It is defined by the regulation by name
It is not. The device list in 21 CFR 872.4565 names matrix bands, matrix retainers and matrix contouring instruments but not wedges. The regulatory home for wedges is the general dental hand instrument classification, as the device records above show.
A wedge is a matrix band
A matrix band and a wedge are separate devices. The GMDN definition describes the wedge as stabilizing or supporting other devices such as a matrix band, not as the band itself. Related single-purpose dental hand instruments, such as the dental curette and the crown remover, are listed separately in the same regulation.
FAQ
What is a dental wedge?
A small single-use dental device introduced between two adjacent teeth for slight separation, typically used when a filling material is placed or to support a matrix band or rubber dam (GMDN 45007 definition, checked 2026-10-31).
Is a dental wedge a medical device in the United States?
Yes. FDA’s device records list dental wedges as Class 1 under product code DZN, “Instruments, Dental Hand,” regulation 21 CFR 872.4565 (openFDA UDI, checked 2026-10-31).
Does 21 CFR 872.4565 name the wedge?
No. The list names the dental matrix band, matrix retainer and operative matrix contouring instrument; it does not include the word wedge (eCFR, checked 2026-10-31).
Are dental wedges supplied sterile?
On the 23 records described as “Dental wedge, single-use,” the sterile flag is false and the single-use flag is true. Check the specific product’s labelling for its status.
Sources
- 21 CFR 872.4565, Dental hand instrument. eCFR, https://www.ecfr.gov/current/title-21/section-872.4565. Date checked: 2026-10-31.
- FDA Product Classification Database, product code EKF. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?id=EKF. Date checked: 2026-10-31.
- openFDA device classification and device UDI APIs (AccessGUDID data, last updated 2026-10-01). https://open.fda.gov/apis/device/udi/ and https://open.fda.gov/apis/device/classification/. Date checked: 2026-10-31. openFDA data are unvalidated and not for medical decisions.
- Kamble S, et al. The Effectiveness of Circumferential and Sectional Matrix Systems in Obtaining Optimum Proximal Contact in Class II Composite Restorations: A Systematic Review. Cureus 2025;17(5):e84967. https://pmc.ncbi.nlm.nih.gov/articles/PMC12204051/. Date checked: 2026-10-31.
