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General product and regulatory information for clinic, lab and supply staff. This is not medical advice; anyone wearing separators should follow their orthodontist’s instructions.
Short answer
Orthodontic separators, also called spacers, are small elastic or metal pieces placed between teeth to create gaps before braces are fitted (WebMD). In FDA records the elastomeric type is classified as “Band, Elastic, Orthodontic” under product code ECI, a Class I device under 21 CFR 872.5410.
Definition and scope
WebMD describes orthodontic spacers as “small elastic or metal separators placed between teeth to create gaps,” and the two names are used for the same item. The gap lets an orthodontist fit bands or brackets later. The separator is a temporary accessory, not the band, bracket or wire itself.
FDA’s regulation for orthodontic appliance and accessories (21 CFR 872.5410) covers devices intended for use in orthodontic treatment that are affixed to a tooth so that pressure can be exerted on the teeth. The regulation lists the preformed orthodontic band, band material, orthodontic elastic band, metal bracket, wire clamp, preformed space maintainer, expansion screw retainer, spring, tube and wire. It does not use the word “separator.” FDA’s own records place separators in this family through the product code described below.
How they are used in practice
Separators are a temporary accessory: they are placed between teeth by the orthodontic team ahead of band or bracket fitting, and are not themselves part of the finished appliance. This page gives general product information only and does not describe placement, removal or care; those follow the orthodontist’s instructions.
Types
- Elastic separators. WebMD names elastic separators as one kind. FDA’s 510(k) database lists an “Orthodontic Elastomeric Separator Module” (K943418, Jon-Ko Products, Inc., decision date 05/23/1995).
- Metal separators. WebMD names metal separators as the other kind.
Materials, sizes, single-use status and latex content are not part of the FDA classification, so those details come from the product label or the manufacturer’s instructions for use.
Regulatory identity and catalogue fields
Patient-facing pages explain what spacers feel like. Supply and clinic staff cataloguing them need the regulatory identity, and FDA’s records give it:
| Field | Value in FDA records | Source |
|---|---|---|
| Classification name | Band, Elastic, Orthodontic | openFDA device classification and 510(k) record K943418 |
| Product code | ECI | openFDA device classification; K943418 |
| Regulation number | 872.5410 | openFDA device classification; K943418 |
| Device class | Class I (general controls) | 21 CFR 872.5410(b); openFDA |
| Premarket notification | Exempt from 510(k) procedures in subpart E of part 807, subject to the limitations in 21 CFR 872.9 | 21 CFR 872.5410(b) |
| Medical specialty | Dental | openFDA device classification |
Class I status and the 510(k) exemption come from the regulation; the classification name and code come from the FDA records.
Where it matters for labs, clinics and supply decisions
A catalogue entry for separators is easier to reconcile with regulatory records when it carries the FDA product code (ECI), the regulation number (872.5410) and the class. The other fields (material, pack contents, single-use status) should be copied from the manufacturer’s label, because the FDA classification does not supply them. For how device classes, 510(k) pathways and exemptions work in general, see FDA medical device regulations: classification, 510(k) and PMA and FDA 510(k) premarket notification. For identifying a specific product by label data, see the UDI guide. Dental practices stocking supplies more broadly may find the dental office medical emergency supply checklist a useful companion.
Common misunderstandings
- Separator versus spacer. Same thing in WebMD’s usage. Neither is a space maintainer: “preformed orthodontic space maintainer” is a separate item in the 21 CFR 872.5410 list.
- Separator versus band or bracket. Separators make room; bands and brackets are the appliance parts fitted afterwards.
- “Class I means unregulated.” Class I devices are still subject to general controls, as the regulation states.
- “The regulation names separators.” It does not; separators appear under the product code ECI “Band, Elastic, Orthodontic.”
FAQ
Are orthodontic separators and orthodontic spacers the same?
Yes. WebMD defines spacers as small elastic or metal separators placed between teeth to create gaps.
How does FDA classify orthodontic separators?
The elastomeric separator module record K943418 is classified “Band, Elastic, Orthodontic,” product code ECI, regulation 872.5410. Devices under 872.5410 are Class I (general controls) and exempt from 510(k) notification, subject to 21 CFR 872.9.
Sources
- U.S. Government, 21 CFR 872.5410, Orthodontic appliance and accessories: ecfr.gov (text also at law.cornell.edu/cfr/text/21/872.5410), checked 2026-10-30.
- U.S. FDA 510(k) database, record K943418, Orthodontic Elastomeric Separator Module: accessdata.fda.gov, checked 2026-10-30.
- openFDA device classification, product code ECI: api.fda.gov, checked 2026-10-30.
- WebMD, Orthodontic Spacers: webmd.com, checked 2026-10-30 (secondary, consumer health source).
