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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 Tofflemire matrix is a dental matrix system: a reusable retainer that holds a thin, disposable metal matrix band around a tooth. “Tofflemire” is a pattern name that many makers use, not a separate FDA device category. FDA’s regulation lists the band and the retainer under the generic names “dental matrix band” and “matrix retainer”.
Definition and scope
The word “Tofflemire” describes a retainer-and-band design, and kits sold under that description come from different manufacturers. The federal records treat the product by function, not by that name. The U.S. National Library of Medicine’s AccessGUDID database describes one manufacturer’s “Tofflemire Matrix Band Kit” with a GMDN term, “Dental matrix band kit” (code 62764), and FDA product code JEP, “Retainer, Matrix”. The GMDN definition calls it a collection of non-sterile devices that form a mould around a tooth before a direct restorative material is placed, and says such a system typically includes a matrix band, a band tensioner, a wedge and forceps.
For the regulation behind the generic names, see dental matrix band and how FDA lists it. This page covers the retainer-and-band system as a supply item and does not repeat that classification detail.
How the system is described in practice
The AccessGUDID record for the Garrison Dental Solutions kit (checked 2026-10-31) shows how a kit is recorded: the listed contents are 270 matrices, 100 wedges and two proximal contact instruments, one small and one large. The record states that the device is not packaged as sterile and that it requires sterilization prior to use, with moist heat or steam as the listed method. Its single-use field is “No”, and the GMDN text says the system is reusable after cleaning and sterilization of the reusable instruments, once consumable products have been replenished.
One distributor’s product explainer (ErgoDenta, checked 2026-10-31) describes two knobs on the retainer: an outer knob that locks the band ends in a slot, and an inner knob that slides the vise to change the loop size. It also describes its own stainless retainers as reusable and its bands as single-use. That is a distributor’s description, not a regulator’s or the maker’s instructions for use.
Types and related concepts
Every row below traces to the AccessGUDID record or to 21 CFR 872.4565.
| Term | What the source says | Source |
|---|---|---|
| Matrix band kit | GMDN 62764, “Dental matrix band kit”; a collection of non-sterile devices | AccessGUDID |
| Retainer, Matrix | FDA product code JEP | AccessGUDID |
| Dental matrix band | Named in the list of dental hand instruments | 21 CFR 872.4565 |
| Matrix retainer | Named in the same list | 21 CFR 872.4565 |
| Wedge, proximal contact instrument | Listed as kit contents in the Garrison record | AccessGUDID |
Distributors also sort Tofflemire-style products by size name (Junior, Universal, Senior) and by band thickness. Those labels vary by seller and are not regulatory categories, so check each maker’s own product sheet for what a given size name means.
Where it matters for labs, clinics and supply decisions
The records support a short reusable-versus-consumable checklist for anyone cataloguing these items. Each point comes from the AccessGUDID record or the CFR text above.
- Is it a kit or a single part? The record lists a kit with bands, wedges and contact instruments together, so a catalogue entry should say which parts it includes.
- Is it supplied sterile? In the Garrison record the answer is no, and sterilization is required before use.
- Which parts are reusable? The GMDN text says the system is reusable after appropriate cleaning and sterilization of the reusable instruments, with consumables replenished.
- Whose reprocessing instructions apply? The method for any given retainer is the one in that manufacturer’s instructions for use; the database record lists only the sterilization method category.
- How is it classified? The generic device names sit in 21 CFR 872.4565, Class I (general controls), with a 510(k) exemption only under the stated conditions and the limitations in 21 CFR 872.9. Related instruments are covered in dental surgical instruments and amalgam carrier.
For the broader idea of what FDA treats as a device, see what is a medical device.
Common misunderstandings
- “Tofflemire” is not a regulatory class. It is a design name used by several manufacturers; the regulation uses the generic terms.
- The whole kit is not single-use. In the record examined, the kit is reusable after reprocessing of the reusable instruments, while consumables such as bands are replenished.
- “Non-sterile” does not mean “ready to use”. The same record says sterilization is required before use.
FAQ
What is a Tofflemire matrix?
It is a retainer-and-band dental matrix system, listed in federal records under generic names such as “dental matrix band kit” and “Retainer, Matrix”.
Is the band reusable?
The AccessGUDID record examined marks the kit as not single-use, reusable once the reusable instruments are cleaned and sterilized and consumables are replenished. A distributor describes the bands as single-use; follow the maker’s instructions for use for each product.
Is a Tofflemire matrix supplied sterile?
In the record examined, no. It is listed as not packaged as sterile and requiring sterilization prior to use.
How does FDA classify it?
The generic names fall under 21 CFR 872.4565, Class I (general controls), with a conditional 510(k) exemption. See dental matrix band for details.
Sources
- U.S. National Library of Medicine, AccessGUDID, Slick Bands Tofflemire Matrix Band Kit record (device identifier 00810038096094), https://accessgudid.nlm.nih.gov/devices/00810038096094, checked 2026-10-31.
- 21 CFR 872.4565, Dental hand instrument, https://www.law.cornell.edu/cfr/text/21/872.4565, checked 2026-10-31.
- ErgoDenta, Tofflemire matrix system product explainer (distributor), https://ergodenta.dk/blog/products-13/tofflemire-matrix-system-matrix-bands-junior-universal-senior-153, checked 2026-10-31.
