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Dental Devices

Devices used in dentistry, implants, CAD/CAM restorations, clear aligners, intraoral scanners, and dental radiography.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 9, 2026

Definition

The dental MedTech segment includes endosseous implants and abutments, CAD/CAM mills and 3D printers for crowns/bridges, clear aligner systems, intraoral scanners, cone-beam CT, and chairside materials. Dental products are regulated by FDA's CDRH under 21 CFR 872, with most clearances via 510(k).

What the regulation says

21 CFR 872 governs dental devices. Endosseous implants are Class II with special controls. Clear aligners straddle Class I (impression materials) and Class II (the aligner system itself). Cone-beam CT systems are Class II radiology devices.

What this means in practice

Direct-to-consumer aligners drove FDA enforcement attention (warning letters tied to lack of in-person dental supervision) and a 2024 SmileDirectClub bankruptcy that reshaped the segment.

Common pitfalls

•Treating clear aligners as a consumer product, FDA regulates them as Class II prescription devices.
•Skipping radiation-safety labeling for cone-beam CT systems.

Grouped by theme

Editor's picks

· Hand-selected related concepts

Regulatory

510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

Software & AI

Software as a Medical Device(SaMD)

Software intended for medical purposes that performs without being part of a hardware device.

More in Market Segments

· Same category

Market Segments

Aesthetic & Energy-Based Devices

Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions.

Market Segments

AI Imaging Software

Software that analyzes medical images to triage, detect, or quantify disease.

Market Segments

Cardiac Rhythm Management(CRM)

Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors.

Market Segments

Cardiovascular Devices

Devices for diagnosing, monitoring, or treating cardiovascular disease.

Primary references

3 sources

Link health: 3 verified· last checked 2026-06-20

eCFR·1FDA·1MedTech Dive·1

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On this term

Category: Market Segments
Sources: 3
Updated: 5/9/2026

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Learn in 60 seconds

Devices used in dentistry, implants, CAD/CAM restorations, clear aligners, intraoral scanners, and dental radiography.

·Direct-to-consumer aligners drove FDA enforcement attention (warning letters tied to lack of in-person dental supervision) and a 2024 SmileDirectClub bankruptcy that reshaped the segment.
·Dental products are regulated by FDA's CDRH under 21 CFR 872, with most clearances via 510(k).

Remember this

Watch out: Treating clear aligners as a consumer product, FDA regulates them as Class II prescription devices.

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