Written and maintained by CASRAI Editorial Board
Last updated
General product information for laboratory and clinic staff; not medical or dental advice.
Short answer
A dental bonding agent is a resin material painted on the inside of a prepared tooth cavity to improve retention of a restoration such as a filling. FDA calls it a “resin tooth bonding agent” (21 CFR 872.3200), a Class II device with product code KLE, which is the name to search under in regulatory records and catalogues.
Definition and scope
The regulation (21 CFR 872.3200) defines a resin tooth bonding agent as “a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.” It is classified as Class II. In FDA’s Product Classification database the entry for product code KLE reads “Agent, tooth bonding, resin”, review panel Dental, Class 2, submission type 510(k).
This page covers the material and how it is identified. It does not describe clinical technique, and it is not guidance for any individual patient.
How it is used in practice
Restorative dentistry relies on adhesive systems that create a durable seal between tooth structure and the restorative material, according to a 2026 systematic review and network meta-analysis in BMC Oral Health. The same paper describes “universal” adhesives as systems that can be used with self-etch, selective-etch or etch-and-rinse strategies, which means the strategy is a feature of how a product is applied, not a separate regulatory category.
The review’s conclusion is cautious: bond strength of universal adhesives appears to depend mainly on the application strategy and the material composition, and further clinical validation is needed. Its evidence comes from in vitro (laboratory) studies of bond strength to dentin.
Types and related concepts
Several nearby dental materials are easy to confuse with a bonding agent in catalogues. The table separates them by the identifiers that sources actually state.
| Material | Regulatory identity or scope statement | Source |
|---|---|---|
| Resin tooth bonding agent | 21 CFR 872.3200, Class II, product code KLE, painted on the interior of a prepared cavity to improve retention of a restoration | 21 CFR 872.3200; FDA product classification, code KLE |
| Tooth shade resin material (composite resin) | 21 CFR 872.3690, Class II, product code EBF; see dental composite resin | CASRAI guide, citing 21 CFR 872.3690 |
| Adhesive luting materials | Outside the scope of ISO 4049; see ISO 4049 for the boundary | CASRAI guide on ISO 4049 |
Other direct restorative materials are covered separately, for example glass ionomer cement. A product for dentures is a different device: see denture adhesive.
Application strategies named for universal adhesives
- Self-etch
- Selective-etch
- Etch-and-rinse
These three strategies are the ones named for universal adhesives in the BMC Oral Health review (2026). They describe use, not classification.
Where it matters for labs, clinics and supply decisions
Record-matching checklist
When a bonding product appears in a catalogue, purchasing record or regulatory search, these identifiers from the FDA sources let the record be matched to the right device type:
- Device name: “Agent, tooth bonding, resin”
- Regulation: 21 CFR 872.3200
- Product code: KLE
- Class: 2 (Class II)
- Submission type: 510(k)
- Review panel: Dental
The openFDA device classification endpoint (data last updated 2026-10-19) lists 421 distinct 510(k) numbers under product code KLE, so many products share this one regulatory identity. A trade name or a “universal” label is not a regulatory identifier; the code and regulation number are.
Cross-check against neighbouring devices
Because a restoration typically involves both a bonding agent and a composite, the two have separate regulations and codes (872.3200 / KLE and 872.3690 / EBF). A record that lists only one does not cover the other. For another dental device read the same way, see carbide bur.
Common misunderstandings
- “Bonding agent” and “composite” are the same thing. They are separate FDA device types with different regulations and product codes.
- “Universal” is a regulatory class. The regulation does not use the word; the review describes it as a product that can be used with more than one etching strategy.
- Laboratory bond-strength results settle clinical performance. The 2026 review itself says further clinical validation is needed.
- The material and the procedure are one subject. The regulation defines a material; this page does not address any procedure.
FAQ
What is a dental bonding agent?
Under 21 CFR 872.3200 it is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
What FDA class and product code does a dental bonding agent have?
The regulation classifies it as Class II. FDA’s Product Classification database lists it as “Agent, tooth bonding, resin”, product code KLE, submission type 510(k), review panel Dental.
Is a “universal” adhesive a separate regulatory category?
No source read for this page gives it one. The 2026 BMC Oral Health review describes universal adhesives as systems usable with self-etch, selective-etch or etch-and-rinse strategies; the regulatory identifiers remain 21 CFR 872.3200 and code KLE.
Is a bonding agent the same as dental composite resin?
No. Composite resin is listed as a tooth shade resin material under 21 CFR 872.3690 (code EBF), a different regulation and product code. See dental composite resin.
Sources
- 21 CFR 872.3200, Resin tooth bonding agent: law.cornell.edu/cfr/text/21/872.3200 (checked 2026-10-31).
- FDA Product Classification database, product code KLE: accessdata.fda.gov, code KLE (checked 2026-10-31).
- openFDA device classification API: open.fda.gov/apis/device/classification (checked 2026-10-31; data last updated 2026-10-19).
- Comparison of universal adhesives used in different etching modes on dentin bond strength: a systematic review and network meta-analysis, BMC Oral Health, 2026, doi 10.1186/s12903-026-08982-4, PMC13527972 (checked 2026-10-31).
