Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only. This page is not medical or dental advice and does not describe how to use any instrument on a patient.
Short answer
A crown remover is a dental hand instrument. FDA lists it as “Remover, Crown” under product code EIS, a Class I device (general controls) regulated under 21 CFR 872.4565, and that regulation names “crown remover” among roughly sixty dental hand instruments. Checked 2026-10-31.
Definition and scope
The regulation defines a dental hand instrument as “a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures.” The instrument list in paragraph (a) includes the crown remover alongside, for example, the burnisher, curettes, elevators and the mouth mirror. The regulation does not describe the design of a crown remover or how it is operated; it classifies the device type by name.
This page covers identification and classification of the device type and the reprocessing framework that applies to dental instruments. It does not cover technique, force, or clinical decision-making, which belong to clinical training and the manufacturer’s instructions for use.
How it fits regulation and use
Three identifiers are enough to find the device in FDA’s public databases:
| Field | Value in the FDA classification record |
|---|---|
| Device name | Remover, Crown |
| Product code | EIS |
| Regulation number | 872.4565 |
| Review panel | Dental (DE) |
| Device class | 1 |
| Implant / life-sustaining | No / No |
Source: openFDA device classification endpoint, record for product code EIS, data last updated 2026-10-19, checked 2026-10-31.
Class I means general controls. Under paragraph (b) of the regulation, a device of this type “made of the same materials that were used in the device before May 28, 1976” is exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 872.9. The exemption therefore carries a condition; it is not a blanket statement that the device is outside FDA oversight.
Related concepts
The nearest related concept is the category itself, the dental hand instrument under 21 CFR 872.4565. Other instruments on the same list have their own guides on this site, including the dental curette, the surgical curette and the dental matrix band (how FDA lists it). For powered instruments, see dental handpiece types.
Terms cross-walk
| Where you see it | Wording |
|---|---|
| 21 CFR 872.4565(a) | “crown remover” |
| FDA classification database | “Remover, Crown” (product code EIS) |
The FDA record uses the inverted form, so “Remover, Crown” and product code EIS are the identifiers to search for in FDA databases.
Where it matters for labs, clinics and supply decisions
The CDC’s guidance on sterilization in dental settings sorts patient-care items by what tissue they contact:
- Critical items “penetrate soft tissue or bone” and “should always be heat sterilized.”
- Semicritical items “touch mucous membranes, like the inside of the cheeks or the gums.” The CDC describes these as carrying a lower transmission risk than critical items.
- Noncritical items “only contact unbroken skin.”
The CDC page does not assign crown removers to a category, and neither does the FDA classification, so the category depends on how the instrument is used. The CDC also states that “the majority of patient-care items in dentistry are heat-tolerant and therefore should be heat sterilized,” that “cleaning is the basic first step in all decontamination processes,” and that blood, saliva and other contamination “can cause the disinfection or sterilization process to fail if it is not removed.” For a specific product, the manufacturer’s instructions for use define the validated reprocessing method.
Common misunderstandings
“Class I means unregulated”
Class I devices are subject to general controls. The premarket notification exemption in 872.4565(b) is conditional on materials and on the limitations in 872.9.
“All crown removers are one product”
The regulation names the device type, not a design. FDA’s classification covers the type; individual products differ and are described by their makers.
“The CDC says how to sterilize a crown remover”
The CDC gives category definitions and general principles. It does not name this instrument.
Frequently asked questions
What is a crown remover?
A hand-held dental instrument. 21 CFR 872.4565 names “crown remover” among the dental hand instruments it classifies; the regulation does not describe its design.
What FDA class and product code does a crown remover have?
Class I (general controls), product code EIS, device name “Remover, Crown”, under regulation number 872.4565.
Is a crown remover exempt from premarket notification?
Conditionally. Under 872.4565(b), a device made of the same materials used before May 28, 1976 is exempt from the subpart E of part 807 procedures, subject to the limitations in 21 CFR 872.9.
Which CDC reprocessing category does it fall in?
Neither the FDA record nor the CDC page assigns one; the category depends on the tissue the instrument contacts, and the manufacturer’s instructions for use define the validated reprocessing method.
Sources
All sources checked 2026-10-31.
- openFDA, device classification, product code EIS: https://api.fda.gov/device/classification.json?search=product_code:EIS
- 21 CFR 872.4565, Dental hand instrument (Cornell Legal Information Institute copy of the CFR): https://www.law.cornell.edu/cfr/text/21/872.4565
- CDC, Best Practices for Sterilization in Dental Settings: https://www.cdc.gov/dental-infection-control/hcp/dental-ipc-faqs/dental-sterilization.html
