Prosthetic devices · 21 CFR 872 Subpart D

Intraoral Camera

To capture the topographical characteristics of teeth or a stone model

FDA codeQJKClass221 CFR872.3661Pathway510(k) exemptCategoryIntraoral cameras
Companies listing it
2118 makers
Brands and models
45
510(k) clearances
00 in five years
FDA name
Intraoral Camera

Companies that list QJK

21 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Align Technology, Inc.United StatesMakeriTero Lumina Pro · iTero Lumina Pro Mobile · iTero Lumina Pro Wand Barrier Sleeves162026
Osstem Implant Co., Ltd.South KoreaMakerSNAP Wired, SNAP Wireless682026
Guangdong JINME Medical Technology Co., Ltd.ChinaMakerIntra Oral Camera (Model: ECO-CAMERA 01, ECO-CAMERA 02, ECO-CAMERA 03)52026
Alliage S/A Industrias Medico OdontologicaBrazilMakerAXR-S Eagle Scan · AXR-S Evolve Scan · Eagle IOS · EVOLVE IOS32024
Ningbo Runyes Medical Instrument Co., Ltd.ChinaMakerTeliCam22026
Beyes Dental IncCanadaMakerBeyes Intraoral Scanner——
Huizhou Videya Technology Co., Ltd.ChinaMaker0.8? · 1? · 1.2? · 1.6? · +2——
Onvet Medical Canada Inc.CanadaMakerIntraoral Camera C1, C2,C3,C4,C5,C6,C7,C8,C9——
one day dental partnerSouth KoreaMakerkage intaloral scaaner——
Shenzhen Xiazhifeng Electronic Co., LtdChinaMakerVisual oral Instrument: FY-B800——
Dongguan Yipincheng Technology Co., Ltd.ChinaMakerIntraoral Camera: 401 402 403 T5 T6 408 406——
DSM Holdings Co., LtdSouth KoreaMakerDeepCAM · EZ-CAM160K · EZ-CAM520K——
Fabrinet Co., Ltd.ThailandMakeriTero Lumina (Scanning unit)——
Foshan Fengyun Medical Technology Co., Ltd.ChinaMakerIntraoral Camera——
ACME Tooling Technology Co., Ltd.TaiwanMaker———
Clear Capture, LCCUnited StatesMakerOHICAN, LCC——
e-con Systems India Private LimitedIndiaMakerDensiCAM——
Shenzhen Besdata Technology Co LtdChinaMakerScopeRemote Medical scope——
Shofu IncJapanContract manufacturerEYECAM962025
A-dec, Inc.United StatesManufacturerKit,Primescan,Clinician · Kit,Primescan,Connection,33X/342 · Kit,Primescan,Connection,53X · Kit,Primescan,Connection,541/341 Dr Side · +3682022
Denterprise International, IncUnited StatesRepacker / relabelerDisposable Cover Sheaths for MD770, iCam, ProSys, EyeCam Intraoral Cameras · EyeCam · EyeCam Intraoral Camera · iCam · +442023

Official records: FDA product classification for QJK · 21 CFR 872.3661.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026