Written and maintained by CASRAI Editorial Board
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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 matrix band is a dental hand instrument that FDA names, by that exact term, in 21 CFR 872.4565. The regulation places it in Class I (general controls) and exempts it from 510(k) premarket notification only under stated conditions. The retainer that holds a band is listed as a separate device.
Definition and scope
The regulation does not describe the device band by band. What it does fix is the device’s regulatory identity: 21 CFR 872.4565 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 contains “dental matrix band,” “matrix retainer” and “operative matrix contouring instrument.”
This sits inside the wider family of dental surgical instruments, and the same regulation covers instruments such as dental extraction forceps. For the general idea of what FDA counts as a device, see what is a medical device.
How the device is identified in practice
For procurement and records staff, the practical question is how to confirm what an item is called and how it is regulated. FDA’s public records give three fixed reference points.
- Regulation number: 872.4565 (dental hand instrument), Title 21 CFR Part 872, Dental Devices.
- Classification: Class I (general controls), as stated in paragraph (b) of the regulation.
- 510(k) records: a cleared submission shows a device name, applicant, decision, product code and regulation number.
A worked example: FDA’s 510(k) database record K071858 is titled “Dental Matrix Band,” from applicant Fly Cast Technologies, Inc. The decision, dated 31 August 2007, is “Substantially Equivalent.” The record lists product code DZN and regulation number 872.4565. Reading a record this way shows which fields identify a device; it does not say anything about the quality of any product sold today.
Related listed devices
The regulation names three matrix-related items separately. Every row below is quoted from 21 CFR 872.4565(a).
| Name as listed in the regulation | What the listing tells you |
|---|---|
| dental matrix band | A named dental hand instrument in the 872.4565 list |
| matrix retainer | A separately named entry, not folded into the band entry |
| operative matrix contouring instrument | A separately named entry for a contouring instrument |
Because the regulation lists these as distinct names, a supplier listing that uses one of the three terms is not automatically describing the others. Read the item name and description against the exact term before treating two listings as equivalent.
Where it matters for labs, clinics and supply decisions
- Match the name to the regulation. If a record, quote or catalogue entry must be tied to the regulatory term, use “dental matrix band” or “matrix retainer” exactly as 872.4565 writes them.
- Check which item you are comparing. A band, a retainer and a contouring instrument are three listed names, so compare like with like.
- Know what the exemption covers. The Class I listing carries a 510(k) exemption only if the device is made of the same materials used in the device before 28 May 1976, subject to the limitations in 21 CFR 872.9. Under 872.9, the exemption applies only to the extent the device keeps the characteristics of its generic type; a different intended use or different fundamental scientific technology still needs a 510(k).
The background on why Class I devices and exemptions exist is in the Medical Device Amendments of 1976, and the clearance route itself is outlined in the FDA 510(k) and De Novo submission guide.
Common misunderstandings
“Class I exempt means unregulated”
No. The regulation states “Class I (general controls).” Exemption removes the 510(k) premarket notification step under the stated conditions; it does not remove the device from the classification regulation, and 872.9 limits the exemption.
“A band and a retainer are one item”
The regulation lists “dental matrix band” and “matrix retainer” as separate names.
“Any 510(k) record for a band proves a current product is cleared”
A record such as K071858 documents one submission by one applicant on one date. It identifies that submission only.
Frequently asked questions
Is a dental matrix band a regulated medical device?
Yes. FDA lists “dental matrix band” among the dental hand instruments in 21 CFR 872.4565, which classifies them as Class I (general controls).
Does a Class I dental matrix band need a 510(k)?
The regulation exempts the device from 510(k) premarket notification if it is made of the same materials used in the device before 28 May 1976, subject to the limitations in 21 CFR 872.9. A different intended use or a different fundamental scientific technology still requires a 510(k).
Is a matrix retainer the same as a matrix band?
No. The regulation lists “dental matrix band” and “matrix retainer” as separate names.
What FDA product code appears on a dental matrix band 510(k) record?
The example record K071858 lists product code DZN and regulation number 872.4565. A different record may differ, so check the record itself.
Sources
- 21 CFR 872.4565, Dental hand instrument: eCFR and Cornell LII. Checked 31 October 2026.
- 21 CFR 872.9, Limitations of exemptions from section 510(k): Cornell LII. Checked 31 October 2026.
- FDA 510(k) database, K071858: accessdata.fda.gov. Checked 31 October 2026.
