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General product and regulatory information only. This page is not medical advice and does not describe how any instrument is used on a patient.
Short answer
A Freer elevator is a hand-held, reusable surgical instrument of the periosteal-elevator type, used to lift or separate tissue from bone. Its US regulatory record depends on the listing: one public device record files a Freer nasal periosteal elevator under FDA product code DZN (dental hand instruments), while the related dental surgical elevator sits under 21 CFR 872.4565 as a Class I device.
Definition and scope
The GMDN term behind the U.S. National Library of Medicine’s AccessGUDID record “Periosteal Elevator Freer Nasal” is “Periosteal elevator, reusable” (term code 38168). GMDN defines it as a hand-held manual surgical instrument designed to lift or separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic. The definition adds that it may also be used in dentistry, and that it is a reusable metal instrument.
“Freer” is the name that appears in the brand name on that record; the record itself gives no history of the name and no dimensions, so this page makes no claim about either.
How it is described in practice
The GMDN definition, as shown in AccessGUDID, describes a hand-held metal instrument with various blade designs. That is the full extent of what the public record says about form. Technique, indications and patient-specific use belong to the manufacturer’s instructions for use and to clinical training, and are outside the scope of this page.
Related classifications
Three labels often appear together in catalogs and device databases. Each comes from a different record, so they are not interchangeable.
| Label | Where it appears | What it says |
|---|---|---|
| GMDN 38168, “Periosteal elevator, reusable” | AccessGUDID record D9282000290 | Hand-held manual surgical instrument that lifts or separates tissue from bone; reusable |
| FDA product code DZN, “Instruments, Dental Hand” | The same AccessGUDID record | The product code that this manufacturer’s record carries |
| FDA product code EMJ, “elevator, surgical, dental” | FDA Product Classification database | Regulation 872.4565, Class I, 510(k) exempt |
21 CFR 872.4565(a) defines a dental hand instrument as a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures, and its list of included devices names the “dental surgical elevator”. The list does not name a periosteal or Freer elevator. Under paragraph (b) the classification is Class I (general controls), and 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. For the history of that device-classification system, see Medical Device Amendments of 1976.
Where it matters for labs, clinics and supply decisions
The GUDID record is a useful check when a catalog entry is unclear. On the Freer nasal record, these fields are the ones that answer common questions:
- GMDN term: “Periosteal elevator, reusable” identifies the instrument type and that it is reusable.
- FDA product code: DZN on this record. A different manufacturer’s record for a similar instrument may carry a different code, such as EMJ, so a catalog that calls the item “dental” or “orthopaedic” is not by itself a regulatory statement.
- Sterile status: the record shows the device is not packaged as sterile, requires sterilization before use, and lists moist heat or steam as the sterilization method.
- Sizes: this record lists none, so size has to come from the manufacturer’s own documentation.
Reusable instruments that arrive non-sterile are reprocessed before use according to the manufacturer’s instructions. For sterile-field context in the same cluster, see what a surgical retractor is, what a sterile drape is and what an electrosurgical unit is.
Common misunderstandings
- “The CFR classifies the Freer elevator.” The regulation names the dental surgical elevator, not the Freer by name. Whether a given product falls under it is a question for that product’s record.
- “Dental or orthopaedic, only one is right.” The GMDN definition describes both settings, and records for similar instruments can carry different product codes.
- “It arrives ready to use.” The cited record shows it is not packaged sterile and requires sterilization first.
- “Class I means unregulated.” Class I devices are subject to general controls; 510(k) exemption concerns premarket notification only.
FAQ
What is a Freer elevator?
A reusable, hand-held surgical instrument of the periosteal-elevator type that lifts or separates tissue from bone, per the GMDN term used in AccessGUDID.
Is a Freer elevator sterile?
On the AccessGUDID record cited here, it is not packaged as sterile and requires sterilization before use, with moist heat or steam listed as the method. Follow the manufacturer’s instructions for the product in hand.
Is a Freer elevator a dental or an orthopaedic instrument?
The GMDN definition says periosteal elevators are typically used in orthopaedic surgery and may also be used in dentistry. The cited record carries the dental hand instrument product code DZN.
Does it need FDA premarket notification?
For the dental surgical elevator under 21 CFR 872.4565, the classification is Class I and exempt from 510(k) if the material condition in paragraph (b) is met. Establishment registration still applies.
Sources
- NLM AccessGUDID, device record “Periosteal Elevator Freer Nasal”, DI D9282000290: accessgudid.nlm.nih.gov/devices/D9282000290. Checked 2026-10-30. GMDN content used under licence from The GMDN Agency.
- FDA Product Classification, product code EMJ: accessdata.fda.gov product classification EMJ. Checked 2026-10-30.
- 21 CFR 872.4565, Dental hand instrument: law.cornell.edu/cfr/text/21/872.4565. Checked 2026-10-30.
