What this market covers
Series of clear removable trays that move teeth step by step as an alternative to metal braces. Prescribed by dentists and orthodontists, with some sold direct to consumers.
Typical segments
- Dentist prescribed aligners
- Direct to consumer aligners
- Retainers
- Teen aligners
Why this market is moving now
- US employment in the core industry shifted +10% since 2020.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The EU had 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies) in 2023. | 63,227 enterprises | 2023 | Eurostat |
| EU enterprises in NACE class C3250 had net turnover of €105.31 billion in 2021. | 105.31 EUR billion | 2021 | Eurostat |
| NACE class C3250 employed 600,000 people across the EU in 2023. | 600,000 persons employed | 2023 | Eurostat |
| The US had 922 private establishments in NAICS 339114 (Dental equipment and supplies manufacturing) in 2025. | 922 establishments | 2025 | U.S. Bureau of Labor Statistics |
| NAICS 339114 employed an average of 16,369 people in US private industry in 2025. | 16,369 jobs | 2025 | U.S. Bureau of Labor Statistics |
| US employment in NAICS 339114 changed by +10% between 2020 (14,843 jobs) and 2025, calculated from BLS figures. | +10 % change | 2025 | U.S. Bureau of Labor Statistics |
| Average annual pay in US NAICS 339114 was $89,386 in 2025. | 89,386 USD per year | 2025 | U.S. Bureau of Labor Statistics |
| The FDA has recorded 3 510(k) clearances for devices named "orthodontic aligner". | 3 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| 1 of those clearances were issued from 2021 to 2025. | 1 510(k) clearances | 2025 | U.S. Food and Drug Administration |
| 3D Global Biotech, Inc. holds 2 510(k) clearances for devices named "orthodontic aligner". | 2 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| Digital Orthodontic Care holds 1 510(k) clearances for devices named "orthodontic aligner". | 1 510(k) clearances | 2026 | U.S. Food and Drug Administration |
| PubMed indexed 9 papers mentioning "clear aligner orthodontic" in the title or abstract in 2025. | 9 papers | 2025 | U.S. National Library of Medicine |
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- Eurostat: Enterprises by detailed NACE Rev. 2 activity and special aggregates (sbs_ovw_act) (2026-11-04)
Quoted lines
- Figure 1
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs ENT_NR, 2023, 63227
- Figure 2
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs NETTUR_MEUR, 2021, 105308
- Figure 3
sbs_ovw_act, geo EU27_2020, nace_r2 C3250, indic_sbs EMP_NR, 2023, 600000
- Figure 1
- U.S. Bureau of Labor Statistics: QCEW annual averages, NAICS 339114, 2025 (2026-11-04)
Quoted lines
- Figure 4
QCEW 2025 annual, US000, private, NAICS 339114, annual_avg_estabs 922
- Figure 5
QCEW 2025 annual, US000, private, NAICS 339114, annual_avg_emplvl 16369
- Figure 6
QCEW 2020 annual_avg_emplvl 14843; 2025 annual_avg_emplvl 16369
- Figure 7
QCEW 2025 annual, US000, private, NAICS 339114, avg_annual_pay 89386
- Figure 4
- U.S. Food and Drug Administration: openFDA 510(k) clearances, device_name "orthodontic aligner" (2026-11-04)
Quoted lines
- Figure 8
openFDA device/510k device_name:"orthodontic aligner", sum of counts by decision_date = 3
- Figure 9
openFDA device/510k decision_date 2021-2025 count = 1
- Figure 8
- U.S. Food and Drug Administration: openFDA 510(k) clearances by applicant, device_name "orthodontic aligner" (2026-11-04)
Quoted lines
- Figure 10
applicant.exact "3D Global Biotech, Inc." count 2
- Figure 11
applicant.exact "Digital Orthodontic Care" count 1
- Figure 10
- U.S. National Library of Medicine: PubMed search "clear aligner orthodontic"[tiab] AND 2025[dp] (2026-11-04)
Quoted lines
- Figure 12
esearch count 9
- Figure 12
Buyers and suppliers
Who buys
- Orthodontists
- Dental clinics
- Consumers
Companies to watch
3D Global Biotech, Inc.
2 FDA 510(k) clearances for devices named "orthodontic aligner".
Digital Orthodontic Care
1 FDA 510(k) clearances for devices named "orthodontic aligner".
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the United States market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
Included with the full report
- PDF report, 40 to 60 pages
- Excel data pack
- Ready-to-use charts
- Method note and assumptions
- Written to order in 5 working days
Frequently asked questions
How many clear aligner devices are cleared by the FDA?
openFDA lists 3 510(k) clearances for devices named orthodontic aligner.
Which companies hold the most FDA clearances for clear aligner?
By 510(k) count: 3D Global Biotech, Inc., Digital Orthodontic Care.
How many US companies are in the clear aligner industry?
BLS counts 922 private establishments in NAICS 339114 (Dental equipment and supplies manufacturing), the closest official industry.
How many EU companies are in the clear aligner industry?
Eurostat counts 63,227 enterprises in NACE class C3250 (Manufacture of medical and dental instruments and supplies).
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