Prosthetic devices · 21 CFR 872 Subpart D
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression System
An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.
- Companies listing it
- 12595 makers
- Brands and models
- 426
- 510(k) clearances
- 50 in five years
- FDA name
- System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
510(k) clearances per year, 1976–2026
Companies that list NOF
125 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | AS200E · AS260 · CARES Abutment · DI-1 · +9 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | Cloudpoint 3D Dental Scanner · fastdesign.io · FinalTouch · Glidewell Restorative CT | 56 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | R2 Photogram · R2i3 · R2i5 | 30 | 2026 |
| Align Technology, Inc. | United States | Maker | Gumlines · iOC Scanner · iTero Element · iTero Element 2 · +14 | 16 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | Carestream Scanner · DTX Studio Design · DTX Studio Lab · KaVo LS3 Scanner · +2 | 94 | 2026 |
| Ray Co., Ltd, | South Korea | Maker | RAYDent Designer · RAYDENT SW · RAYiOS · RAYiOS2 | 21 | 2026 |
| GC America Inc. | United States | Maker | Aadva Lab Scanner 2 · Aadva Lab Scanner 3 · Coe Cal · FujiRock · +5 | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Lythos | 203 | 2026 |
| Chengdu Besmile Medical Technology Co., Ltd. | China | Maker | Intraoral Scanner | 5 | 2026 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Bio Plan Software - Crown and Bridge Module | 20 | 2024 |
| X-NAV Technologies, LLC. | United States | Maker | FastMap · FastMap Navigated Photogrammetry · X-Guide FastMap | 6 | 2026 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Intra Oral Scanner (Model: ECO-SCANNER 1, ECO-SCANNER 2) | 5 | 2026 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | Intraoral Scanner, Helios 600, Helios 500, MyScanner, Helios 680, Helios 560, Helios 700, INNO SCAN | 4 | 2026 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | insta one · Intraoral Scanner · Smile2, K-Scan, Smile Scan · Swift Scan | 3 | 2026 |
| 3Shape Trios | Denmark | Maker | S1P-2 scanning tip · Trios 3 · TRIOS 3 Wireless · TRIOS 4 · +7 | 3 | 2026 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | China | Maker | GUSROM · Intraoral Scanner ,YRC-S03 | 3 | 2023 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Dentca, Inc. | United States | Maker | DENTCA Design · Pala Design Studio | 6 | 2026 |
| Pac-Dent Inc. | United States | Maker | Rodin IO | 5 | 2022 |
| ClaroNav Inc. | Canada | Maker | MicronMapper · MicronMapper EVO · TissueMapper | 3 | 2024 |
| Ningbo Runyes Medical Instrument Co., Ltd. | China | Maker | All-in-one Photogrammetry Camera iGrapher Pro · All-in-one Photogrammetry Camera iGrapher Trinity · Intraoral Scanner 3DS Mega · Intraoral Scanner 3DS Ultra · +13 | 2 | 2026 |
| Dental Imaging Technologies Corporation | United States | Maker | DEXIS Imprevo · DEXIS IS 3700 · DEXIS IS 3800 · DEXIS IS 3800W · +1 | 2 | 2026 |
| Hunan Vsmile Biotechnology Co.,Ltd | China | Maker | Intraoral Scanner, VLS100 | 2 | 2024 |
| Fussen Technology Co., Ltd | China | Maker | Fussen, Digital Intraoral Scanner System S6000 · Fussen, Digital Intraoral Scanner System S6500 · Fussen, Digital Intraoral Scanner System S7000 S7000 Premium · Fussen,Digital Intraoral Scanner System S10 | 2 | 2026 |
| Planmeca Oy | Finland | Maker | Planmeca Emerald · Planmeca Emerald S · Planmeca Onyx | 25 | 2023 |
| DIO Corporation | South Korea | Maker | MEDIT-i500 · MEDIT-i700 · MEDIT-i700 wireless · MEDIT-i900 | 14 | 2023 |
| Hdx Will Corp. | South Korea | Maker | Real Arch | 6 | 2021 |
| Trident SRL | Italy | Maker | Imagen Scan · TriScan | 5 | 2023 |
| Good Doctors Co., Ltd. | South Korea | Maker | IC-DZ21(Intra Oral Camera) · IC-HCN30(Intra Oral Camera) · IC-HCP31(Intra Oral Camera) · IC-MOZ40(Intra Oral Camera) · +1 | 5 | 2023 |
| KaVo Dental GmbH | Germany | Maker | KaVo multiCAD - 108.9312 · KaVo multiCAD Aufbissschienen - 109813 · KaVo multiCAD Eierschalenprovisorium - 109814 · KaVo multiCAD virtueller Artikulator ARCUSdigma - 109812 · +1 | 2 | 2021 |
| Guangzhou Ajax Medical Equipment Co., Ltd. | China | Maker | Intraoral Scanner(Model: AJS1, AJS2, AJS3) | 1 | 2026 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Digital Intraoral Scanner System | 1 | 2023 |
| Hangzhou ChohoTech Co., Ltd | China | Maker | Intra oral camera (Ultra-S, Ultra-M, Ultra-L, Ultra-BP, Ultra-AP, Pro-S, Pro-M, Pro-L, Pro-BP, Pro-AP) · LingOral Dental Design System · Retractor (iScan-AP); | 1 | 2026 |
| ODS Co., Ltd. | South Korea | Maker | Scan Cure (SC-80) | 1 | 2025 |
| Changsha Honchon Technology Co., LTD | China | Maker | Intraoral Scanner,HCE-IS-130,HCE-IS-300,HCE-IS-500,HCE-IS-800 | 1 | 2022 |
| Hefei Meyer Optoelectronic Technology Inc. | China | Maker | Intraoral Scanner | 1 | 2026 |
| 3Shape A/S | Denmark | Maker | Automate · E1 scanner · E2 Scanner · E3 Scanner · +41 | 7 | 2020 |
| Cortex Dental Implants Industries Ltd. | Israel | Maker | CORSCAN Digital Intraoral Scanner system | 4 | 2019 |
| Dexcowin Co., Ltd. | South Korea | Maker | iCam Plus · RayCam | 4 | 2017 |
| GNI Co., LTD | South Korea | Maker | 3D Intraoral Scanner | 3 | 2021 |
| Manufacturera Dental Continental | Mexico | Maker | i500: MD-ID300 Dental Scanner · Medit i700 Dental Scanner · Medit i700 Wireless Dental Scanner | 2 | 2001 |
| exocad GmbH | Germany | Maker | Ceramill Mind DRS · ChairsideCAD | 1 | 2021 |
| 3DISC Americas | United States | Maker | AVA · Heron IOS · OVO 3 · OVO IOS | 1 | 2013 |
| Inteware Co., Ltd | Taiwan | Maker | AirDesign · EZCAD | 1 | 2019 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | Intraoral Scanner | — | — |
| Medit Corp. | South Korea | Maker | i500 · i600 · i700 · i700 wireless · +21 | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | iSuni, Intraoral Scanner, 3D, IOS, oScan, Model 1, Model 2, Model 3, Model 5, Model 6, Model 7, Model 8, Model 9, | — | — |
| one day dental partner | South Korea | Maker | kage System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | — | — |
| BLZ Technology (Wuhan) Co., Ltd. | China | Maker | DS100 · DS200 · DS300E · DS360+ · +17 | — | — |
| Shining 3D Tech Co., Ltd. | China | Maker | AccuFab-CEL · ACCUFAB-F1 · Aoralscan 2, Aoralscan 3, Intelliscan 3X, ez2scan, Detection Eye · Aoralscan Elf Pro · +7 | — | — |
| Digital Dental Depot Limited | Hong Kong SAR China | Maker | NOF / System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations · System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Intraoral Scanner | — | — |
| Alliedstar Medical Equipment Co., Ltd. | China | Maker | AS 100 · AS 200E · AS 260 · AS 260a · +12 | — | — |
| Shenzhen UP3D Tech Co., Ltd. | China | Maker | Intraoral ScannerUP600,UP610 · 3D Scanner, UP1000 · 3D Scanner, UP400 · 3D Scanner,UP200 · +10 | — | — |
| Smart Optics Sensortechnik GmbH | Germany | Maker | Aadva Lab Scanner 2 · Aadva Lab Scanner 2+ · Aadva Lab Scanner 3 · Ds Production · +8 | — | — |
| Dentaco GmbH & Co. KG | Germany | Maker | E4D Accent · IPS Contrast Spray chairside · scan dry · Scan dry plus · +3 | — | — |
| Digital Dental Depot | China | Maker | Ststem, optical impression computer assisted design and manufactureing (Cad/cam) of dental restorations | — | — |
| Nam A Dental Medicine Company Limited | Vietnam | Maker | All Ceramic Prosthesis · Implant-Supported Prosthesis · Porcelain-Fused-to-Metal Prosthesis | — | — |
| DDS Inc. | South Korea | Maker | COMFORT+ · DM5000 · NEXOD · RAY Mill C · +3 | — | — |
| Dongguan Xinletian Dental Equipment Co., Ltd. | China | Maker | Dental Implant Scan Body | — | — |
| Huvitz Company Ltd | South Korea | Maker | IntraOral Scanner LS-100 · IntraOral Scanner LSO-100 · Lilivis CAD L-CAD · LS-100-TIP-3R · +3 | — | — |
| IDS Korea | South Korea | Maker | Nobel Biocare | — | — |
| iRay Group | China | Maker | iScan | — | — |
| Proto3000 Inc. | Canada | Maker | Medit Scanner | — | — |
| PIC dental LLC | United States | Maker | PIC system · PIC system gravity · PIC system station | — | — |
| DOF Inc | South Korea | Maker | FREEDOM Air · FREEDOM i | — | — |
| iRay Imaging Technology Taicang Limited | China | Maker | iScan | — | — |
| Manix Co., Ltd. | South Korea | Maker | Manix MA-4, MD-4, MD-5, ZX-4, ZX-4SA, ZX-4SD, ZX-5SA, XZ-5SD, PT-1, ZX-4A, CS-41 | — | — |
| Arcreal Inc. | South Korea | Maker | ARC-IOS100, ARC-IOS100H · Arcscan · Intraoral Scanner | — | — |
| Atomica Technology, Inc | United States | Maker | Atomica CAD · Atomica Scanner | — | — |
| CADstar Technology GmbH | Austria | Maker | CS.Neo2 · CS.Neo2Max · CS.Neo2Pro | — | — |
| Fabrinet Co., Ltd. | Thailand | Maker | iTero Lumina | — | — |
| Scan4all SAS | France | Maker | IRIS By Starck · WoW | — | — |
| Ziyang Freqty Medical Equipment Co., Ltd. | China | Maker | Intraoral Digital Impression Instrument, PANDA P2,PANDA P2 Plus, PANDA P3, PANDA smart p, PANDA smart y, ELETRA SMART · PANDA free, PANDA P3 Plus, PIOS-EX5 | — | — |
| CBD Dental Lab, Inc. | China | Maker | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | — | — |
| Chunzhi Medical Technology (Nanjing) Co., Ltd. | China | Maker | Customized Denture · Intraoral Scanner | — | — |
| Ori Inc. | United States | Maker | Ori IOS 3 · ORI ONE | — | — |
| Primo Medical Group, Inc | United States | Maker | — | — | — |
| Thanh Dental Laboratory | Vietnam | Maker | Thanh Dental Lab Dental Restorations | — | — |
| Tupel Ltd | United Kingdom | Maker | Tupel 3D Implant Scanner · Tupel 3D Scan-Tracks | — | — |
| Circle Anatoscope Intuitive Design | France | Maker | Circle One | — | — |
| CMEOS Medical Sci & Tech (Wuxi) Co., Ltd. | China | Maker | Dental Extraoral Scanning Photogrammetry System CMX1 | — | — |
| Diamond Dental Lab - Branch Diamond Dental Group Company Lim | Vietnam | Maker | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | — | — |
| Digital Dental Fusion | South Korea | Maker | Novaflow | — | — |
| Fussen Imaging Co.,Ltd. | China | Maker | Digital Intraoral Scanner System(Model:S10, S10P Wireless, S10L Wireless, S10E Wireless, S10D Wireless) | — | — |
| Guangdong Launca Medical Device Technology Co., Ltd. | China | Maker | Intraoral Scanner DL-202,DL-206,DL-206P,DL-300,DL-300P,DL-300 Wireless,Dualscan,Breezyscan | — | — |
| Imagoworks Inc. | South Korea | Maker | Dentbird Crown | — | — |
| INNO3D Co., Ltd. | South Korea | Maker | DENSFLO SCAN (MODEL:IDT-1000) | — | — |
| LargeV Instrument Corp., Ltd. | China | Maker | Intraoral Scanner, FusionScanner SU, FusionScanner SU Lab, FusionScanner SU Pro | — | — |
| Shenzhen Shuhe Technology Co., Ltd | China | Maker | Intraoral Scanner,YRC-S05,GSCAN IQ | — | — |
| JENOPTIK Optical Systems GmbH | Germany | Maker | — | — | — |
| Konzelmann GmbH | Germany | Maker | — | — | — |
| Shen FU Arts Lab | China | Maker | — | — | — |
| Zelia Dental Lab LLC | United States | Maker | — | — | — |
| Cefla S.C. | Italy | Manufacturer | AlphaScan WL · AlphaScan WR · MyScan WL · MyScan WR · +3 | 15 | 2026 |
| B.t.i. Biotechnology | Spain | Foreign exporter | — | 14 | 2024 |
| Liaoning Upcera Co., Ltd | China | Contract manufacturer | FLNTScan R1;FLNTScan R1 Pro;FLNTScan R1 Cart;FLNTScan R2;FLNTScan R2 Pro;FLNTScan R2 Air;FLNTScan R2 Pod;FLNTScan R2 Car | 10 | 2026 |
| Dental Direkt GmbH | Germany | Contract manufacturer | i700 | 9 | 2024 |
| PaloDEx Group Oy | Finland | Foreign exporter | — | 9 | 2024 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Manufacturer | Powder Scan Spray | 8 | 2026 |
| Neoss AB | Sweden | Foreign exporter | Intra-Oral Scanner, NeoScan | 10 | 2022 |
| Amann Girrbach AG | Austria | Foreign exporter | 179130 Ceramill Map 200 · 179130-IDC IDC S2 · 179130NC Ceramill Map 200+ · 179140 Ceramill Map 400 · +6 | 3 | 2026 |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Intraoral Scanner | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Manufacturer | SCANNER INTRAORAL IOS - DENTALINK | — | — |
| Digital Age Dental Laboratories, Ltd. | United States | Contract manufacturer | 3 Shape Lab Scanner | — | — |
| Ray America Inc. | United States | Lister | RAYDENT SW · RAYiOS · RAYiOS2 | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Intraoral Scanner(Model: AJS1, AJS2, AJS3) | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Planmeca Oy | — | — |
| Zhongshan Miiyen New Material Technology Co., Ltd. | China | Foreign exporter | ELETRA SMART · Intraoral Digital Impression Instrument · PANDA Free · PANDA P2 · +6 | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | FLNTScan R1;FLNTScan R1 Pro;FLNTScan R1 Cart;FLNTScan R2;FLNTScan R2 Pro;FLNTScan R2 Air;FLNTScan R2 Pod;FLNTScan R2 Car | — | — |
| Shanghai Smartee Denti-Technology Co., Ltd. | China | Foreign exporter | AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro; · Owandy ios; Owandy ios Wireless; ST 200E | — | — |
| Mountain Dental Lab Service Inc | United States | Repacker / relabeler | SHEN FU ARTS LAB | — | — |
| Onestopdentalstudio Inc | United States | Repacker / relabeler | System, optical impression, computer assisted design and manufacturing (Cad/cam) of dental restorations | — | — |
| TD Dental Supply, Inc. | United States | Repacker / relabeler | — | — | — |
| JSB Dental, Inc. | United States | Repacker / relabeler | D496502 | — | — |
| Wise Way (HK) Trading Limited | Hong Kong SAR China | Foreign exporter | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | — | — |
| Boca Dental Regenerative, LLC. | United States | Lister | — | — | — |
| Contec Americas | United States | Repacker / relabeler | Contec Americas Inc. | — | — |
| Master Dental Studio | United States | Repacker / relabeler | Master Aligner | — | — |
| Medit USA, Inc. | United States | Lister | fastscan.io Intraoral Scanner; fastscan.io Wireless Intraoral Scanner; i500; i600; i600 wireless; i700; i700 wireless; | — | — |
| Pinnacle One Laboratory Services | United States | Repacker / relabeler | CAD designed dental restorations | — | — |
| Streamline Dental Laboratory | United States | Repacker / relabeler | CAD/CAM RESTORATION | — | — |
| All Ways Dental LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 5 Dec 2014 | K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM | Sybron Dental Specialties |
| 8 Feb 2013 | K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE | Sybron Dental Specialties |
| 20 Nov 2012 | K122467 | 3M TRUE DEFINITION SCANNER | 3M Company |
| 5 Sep 2008 | K081961 | 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies |
| 21 Dec 2007 | K073199 | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies |
Official records: FDA product classification for NOF · 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