--- title: "Dental Devices, Definition | MedTech Terms" description: "Devices used in dentistry, implants, CAD/CAM restorations, clear aligners, intraoral scanners, and dental radiography." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/dental-devices#term", "name": "Dental Devices", "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Dental Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Dental Devices Devices used in dentistry, implants, CAD/CAM restorations, clear aligners, intraoral scanners, and dental radiography. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/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. ## Related terms 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. ](/terms/510k)[ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd) ### 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. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 MedTech Dive· 1 1. [1 21 CFR 872 Dental Devices Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-872) 2. [2 FDA, Dental Devices Overview Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/products-and-medical-procedures/dental-devices) 3. [3 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=dental-devices) Learn in 60 seconds Card Lesson Quiz 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. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Software as a Medical Device(SaMD) ](/terms/samd) You may also need Auto-suggested from Market Segments and shared keywords. - [Urology Devices ](/terms/urology-devices) - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Hearing Devices ](/terms/hearing-devices) - [In Vitro Diagnostics(IVD) ](/terms/ivd) - [Renal Care Devices ](/terms/renal-care-devices) - [Drug Delivery Devices ](/terms/drug-delivery-devices) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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