Reference

Clear Aligner Industry Glossary

Plain-language definitions for the terms that come up most in clear aligner manufacturing, business models, and regulatory compliance.

Attachment
A small, tooth-colored composite bump bonded to a tooth to give an aligner extra grip for movements like rotation or extrusion that clear plastic alone can't reliably produce.
CAPA (Corrective and Preventive Action)
A formal quality-system process, required under ISO 13485, for investigating a defect or nonconformance, fixing the immediate problem, and addressing its root cause to prevent recurrence.
CE Marking
A conformity marking indicating a product meets the applicable health, safety, and environmental requirements to be sold in the European Economic Area.
Chairside Refinement
A treatment adjustment made directly at the practice, as opposed to a refinement that requires new scans sent back to a treatment planning team.
Class I Malocclusion
A bite classification where the molar relationship is normal, but individual teeth are crowded, spaced, or rotated.
Class II Malocclusion
A bite classification where the lower jaw and lower molars sit further back relative to the upper molars than in a normal bite, often producing an overbite appearance.
Class III Malocclusion
A bite classification where the lower jaw and lower molars sit further forward relative to the upper molars than in a normal bite, often producing an underbite appearance.
DSO (Dental Support Organization)
A business that provides non-clinical support (administration, purchasing, marketing, sometimes shared clinical infrastructure) to multiple affiliated dental practices, allowing dentists to focus on patient care.
Essix Material
A brand family of copolyester (PETG) sheet material from Raintree Essix, commonly used for clear aligners and retainers; Essix ACE and Essix PLUS are common variants within the line. See the full material comparison →
EU MDR (EU Medical Device Regulation)
The regulatory framework governing medical devices sold in the European Union, which replaced the earlier Medical Device Directive and introduced stricter clinical evidence and post-market surveillance requirements.
FDA 510(k) Clearance
A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device, allowing it to be sold in the US without going through full Premarket Approval (PMA). Read the full explainer →
Flexural Modulus
A measure of a material's stiffness, describing how much a sheet resists bending under a given force. Used in lab testing to compare aligner materials.
Force Decay
The gradual weakening of an aligner's grip on the teeth over the course of a wear cycle, as the plastic relaxes. Multi-layer materials are often engineered to slow this process.
Intraoral Scanner
A handheld device used to capture a digital 3D impression of a patient's teeth, replacing physical impression material as the starting record for aligner treatment planning.
IPR (Interproximal Reduction)
The controlled removal of a small amount of enamel between two teeth to create space for alignment, used as an alternative or supplement to expansion or extraction.
ISO 13485
An international standard specifying requirements for a quality management system for organizations that design, produce, or service medical devices, widely required of aligner manufacturers. Read the full explainer →
Malocclusion
Any misalignment of the teeth or incorrect relationship between the upper and lower dental arches when they come together.
MHRA (Medicines and Healthcare products Regulatory Agency)
The regulatory body responsible for medical device and medicine safety in the United Kingdom.
MOQ (Minimum Order Quantity)
The smallest quantity or volume a supplier requires a customer to commit to per order or over a given period; a low or absent MOQ makes it easier to start with a single case.
ODM (Original Design Manufacturer)
A manufacturer that designs and builds a product (or a full clinical/production process) which a customer then sells under its own brand, typically with more input from the manufacturer's own design or clinical team than a pure OEM relationship.
OEM (Original Equipment Manufacturer)
In this context, a manufacturer that produces a product to a customer's own specifications, for the customer to brand and sell as their own.
Overcorrection
Intentionally planning tooth movement slightly beyond the final target position, to account for minor relapse (teeth settling back) after active treatment ends.
Private Label
An arrangement where a manufacturing partner produces a product under a customer's own brand, typically with more input into materials or design specifics than a pure white label rebrand. Read the full explainer →
Refinement
A mid-treatment or end-of-treatment adjustment to the original aligner plan, based on new scans, to correct for teeth not tracking exactly as planned.
Retainer
A device worn after active aligner treatment to hold teeth in their new position; often made from the same or similar material family as the aligners themselves (such as Essix or Zendura).
STL File
A standard 3D file format used to represent a digital scan or model, most commonly the format intraoral scanners export for submission to a treatment planning team.
Thermoforming
The manufacturing process of heating a plastic sheet until pliable and forming it over a 3D-printed model of a treatment stage to produce a single clear aligner.
Traceability
The ability to trace a product's materials and production steps back through the manufacturing chain, typically to a specific batch or lot, required under quality standards like ISO 13485.
Treatment Staging
The process of dividing the full course of tooth movement into a sequence of discrete steps, each corresponding to one aligner in the series.
TGA (Therapeutic Goods Administration)
The regulatory body responsible for medical device and medicine safety in Australia.
White Label
An arrangement where a manufacturing partner produces an existing, pre-designed product with minimal changes, which the customer rebrands and sells under its own name. Read the full explainer →
Zendura Material
A brand family of polyurethane-based sheet material from Bay Materials, used for clear aligners and retainers; Zendura FLX is a multi-layer variant engineered to reduce force decay. See the full material comparison →

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