Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Who uses them: dentists, oral surgeons and their clinical and sterile-processing staff; this overview is for clinic staff, buyers and students who need to know what the class includes, how FDA regulates it and how the instruments are reprocessed.
What dental surgical instruments are
Dental surgical instruments are the hand-held instruments used in oral surgery procedures, such as the bone chisels, elevators, forceps and curettes named below. In the United States, FDA does not regulate them as a separate group. They sit inside one device family, the dental hand instrument, defined in 21 CFR 872.4565 as "a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures." The same regulation also covers non-surgical instruments such as operative, endodontic, periodontic and orthodontic ones, so "surgical" is a naming and use distinction inside that list rather than a separate regulatory class.
Instrument types named in the FDA regulation
The regulation lists the devices it covers by name. The table shows the entries that carry the word "surgical" in the regulation, plus three shared instruments that the same list also names. Each name is quoted from 21 CFR 872.4565(a).
| Name in 21 CFR 872.4565(a) | Wording in the regulation’s list |
|---|---|
| Surgical bone chisel | Named "surgical" |
| Surgical curette | Named "surgical" (the list also has separate operative, endodontic and periodontic curettes) |
| Dental surgical elevator | Named "surgical" |
| Surgical bone file | Named "surgical" (the list also has separate operative margin finishing, periodontic and endodontic files) |
| Surgical rongeur forceps | Named "surgical" |
| Surgical tooth extractor forceps | Named "surgical" |
| Surgical hemostat | Named "surgical" |
| Surgical biopsy punch | Named "surgical" |
| Surgical osteotome chisel | Named "surgical" |
| Surgical tissue scissors | Named "surgical" |
| Dental retractor and dental retractor accessories | Named without a prefix, in the same list |
| Dental instrument handle | Named without a prefix, in the same list |
| Mouth mirror | Named without a prefix, in the same list |
The regulation names many more devices that are not surgical, including operative explorers, endodontic files and reamers, and orthodontic pliers. Explorers and mirrors are covered on dental explorer types. For a single named elevator, see Freer elevator; for retractors in general, see what a surgical retractor is. Bone-focused instruments for orthopedic surgery are a different group, described in orthopedic surgical instruments.
FDA class and premarket status
Under 21 CFR 872.4565(b), dental hand instruments are Class I, subject to general controls. If a device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 872.9. Class I describes FDA’s regulatory risk class for the device type; it is a different thing from the CDC’s reprocessing categories below.
Why most surgical instruments are "critical" items
CDC sorts patient-care items by how they contact the patient. Critical items penetrate soft tissue or bone, carry the highest risk of transmitting infection and "should always be heat sterilized." Semicritical items touch mucous membranes such as the inside of the cheeks or the gums. Noncritical items contact only unbroken skin. Instruments that cut, elevate or remove tissue or bone in oral surgery fall on the critical side of this scheme whenever they penetrate soft tissue or bone, which is why the reprocessing rules for the class are the strictest ones in CDC’s dental guidance. The FDA name of an instrument does not decide its CDC category; how it contacts the patient does.
How to choose and check an instrument
- Match the product to the regulation’s name. A listing for an instrument in this class should correspond to a device name in 21 CFR 872.4565(a), which is the identification FDA uses.
- Check the manufacturer’s Instructions for Use. CDC says to always follow the manufacturer’s validated Instructions for Use when reprocessing items.
- Check heat tolerance. CDC states that heat-tolerant or disposable alternatives are available for the majority of heat-sensitive semicritical items, and that critical items should always be heat sterilized.
Safe use and handling basics
- Clean first. CDC: "Cleaning is the basic first step in all decontamination processes." Blood, saliva and other contamination can cause the disinfection or sterilization process to fail if it is not removed.
- Heat sterilize critical items following the manufacturer’s validated Instructions for Use. For how sterilizers work, see what an autoclave is and sterilization technology.
- Keep sterilized instruments wrapped. CDC says that once instruments are unwrapped or handled with nonsterile gloves, sterility cannot be guaranteed, and discourages even temporary storage of unwrapped semicritical instruments.
- Unwrapped (flash) sterilization is not for routine use. CDC says it is not a viable method of sterilization to be used on a routine basis and should not be used for reasons of convenience, as an alternative to buying additional instrument sets, or to save time.
Common mistakes
- Treating "Class I" as a statement about reprocessing. FDA class and CDC’s critical/semicritical/noncritical categories answer different questions.
- Assuming every dental hand instrument is surgical. The regulation covers operative, endodontic, periodontic and orthodontic instruments too.
- Skipping cleaning because the instrument will be sterilized afterwards. CDC says contamination left on an instrument can cause sterilization to fail.
- Unwrapping instruments for quick reuse; CDC says unwrapped (flash) sterilization is not consistent with its recommendations for routine use.
FAQ
What counts as a dental surgical instrument?
For FDA purposes, the surgical entries in the dental hand instrument list of 21 CFR 872.4565(a): surgical bone chisel, surgical curette, dental surgical elevator, surgical bone file, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, surgical biopsy punch, surgical osteotome chisel and surgical tissue scissors, with shared instruments such as dental retractors, handles and mouth mirrors.
Are dental surgical instruments regulated by FDA?
Yes. They are dental hand instruments under 21 CFR 872.4565, Class I (general controls), with a premarket notification exemption for devices made of the same materials used before May 28, 1976, subject to 21 CFR 872.9.
Do they have to be heat sterilized?
CDC’s dental sterilization page (dated May 15, 2024) says critical items, which penetrate soft tissue or bone, should always be heat sterilized, after cleaning and following the manufacturer’s validated Instructions for Use.
