Data / Medical devices / 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 (NOF): 112 FDA-registered makers in 22 countries

Name: FDA-registered makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

112 establishments in 22 countries are registered with the FDA to make System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (product code NOF, Class 2, 21 CFR 872.3661). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on December 5, 2014, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: NOF
Device class: 2
Regulation: 872.3661
Medical specialty: Dental

Makers by country

Country	Makers
China	33
South Korea	20
United States	18
Germany	9
Canada	4
Mexico	3
Vietnam	3
Switzerland	3
Denmark	2
Israel	2
France	2
Belgium	2
Italy	2
Poland	1
Austria	1
Hong Kong	1
Thailand	1
Spain	1
Taiwan	1
Sweden	1
Finland	1
United Kingdom	1

Makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Ormco Corporation	Pomona, CA, United States	Complaint file establishment, Specification developer	2	December 5, 2014	api.fda.gov
Ormco Corporation	Brea, CA, United States	Complaint file establishment, Specification developer	2	December 5, 2014	api.fda.gov
3D Imaging And Simulation Corp. Americas	Herndon, VA, United States	Manufacturer	0		api.fda.gov
3shape Trios A/S	copenhagen Hovedstaden, Denmark	Specification developer	0		api.fda.gov
3Shape A/S	Copenhagen Hovedstaden, Denmark	Specification developer	0		api.fda.gov
3Shape Inc.	Morrisville, NC, United States	Contract manufacturer	0		api.fda.gov
3Shape Poland Sp. zo.o	Szczecin Zachodniopomorskie, Poland	Contract manufacturer	0		api.fda.gov
Alliedstar Medical Equipment Co., Ltd.	Ziyang Sichuan, China	Manufacturer	0		api.fda.gov
Arcreal Inc.	Seoul, South Korea	Manufacturer	0		api.fda.gov
Atomica Technology, Inc	Atlanta, GA, United States	Manufacturer	0		api.fda.gov
Align Technology, Ltd.	Petach Tikva Central, Israel	Manufacturer	0		api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, Mexico	Manufacturer	0		api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, Mexico	Manufacturer	0		api.fda.gov
Blue Sky Bio, LLC	Libertyville, IL, United States	Specification developer	0		api.fda.gov
BLZ Technology (wuhan) Co., Ltd.	Wuhan Hubei, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Cadstar Technology GMBH	Bischofshofen Salzburg, Austria	Manufacturer	0		api.fda.gov
CBD Dental Lab, Inc	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Changsha Honchon Technology Co., Ltd	Changsha Hunan, China	Manufacturer	0		api.fda.gov
Changzhou Sifary Medical Technology Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	0		api.fda.gov
Chengdu Besmile Medical Technology Co., Ltd.	Chengdu Sichuan, China	Manufacturer	0		api.fda.gov
Circle Anatoscope Intuitive Design	Meylan Isere, France	Manufacturer	0		api.fda.gov
Cmeos Medical Sci & Tech (wuxi) Co., Ltd.	Wuxi Jiangsu, China	Manufacturer	0		api.fda.gov
Cortex Dental Implants Industries Ltd.	Shlomi Northern, Israel	Manufacturer	0		api.fda.gov
Chunzhi Medical Technology (Nanjing) Co., Ltd.	Nanjing Jiangsu, China	Manufacturer	0		api.fda.gov
ClaroNav Inc.	Toronto Ontario, Canada	Manufacturer	0		api.fda.gov
DDS Inc.	Yongin-si Gyeonggi, South Korea	Manufacturer	0		api.fda.gov
DENTACO GmbH & Co. KG	Essen North Rhine-Westphalia, Germany	Manufacturer	0		api.fda.gov
Dentca, Inc.	Irvine, CA, United States	Manufacturer	0		api.fda.gov
Dexcowin Co., Ltd.	Seoul, South Korea	Manufacturer	0		api.fda.gov
Diamond Dental Lab - Branch Diamond Dental Group Company Limited	Tan Son Hoa Ward, Ho Chi Minh, Vietnam	Manufacturer	0		api.fda.gov
Digital Dental Depot	zhuhai Guangdong, China	Contract manufacturer, Manufacturer, Repackager or relabeler	0		api.fda.gov
Digital Dental Depot Limited	Hong Kong, Hong Kong	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
Digital Dental Fusion Korea	Seoul, South Korea	Manufacturer	0		api.fda.gov
DIO Corporation	Haeundae-gu Busan, South Korea	Exporter to the US, Manufacturer	0		api.fda.gov
Dof Inc	Seoul, South Korea	Manufacturer	0		api.fda.gov
Dental Imaging Technologies Corporation	Quakertown, PA, United States	Complaint file establishment, Manufacturer	0		api.fda.gov
Dental Wings Inc.	Montreal Quebec, Canada	Contract manufacturer, Manufacturer	0		api.fda.gov
Dentsply Sirona Orthodontics Inc.	Sarasota, FL, United States	Contract manufacturer	0		api.fda.gov
Exocad GMBH	Darmstadt Hesse, Germany	Manufacturer	0		api.fda.gov
Envista (Suzhou) Medical Device Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		api.fda.gov
Envista (Suzhou) Medical Device Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		api.fda.gov
Fabrinet Co., Ltd.	Sriracha Chon Buri, Thailand	Contract manufacturer	0		api.fda.gov
Fussen Imaging Co.,ltd.	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Fussen Technology Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
GC Europe N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	0		api.fda.gov
GNI Co., LTD	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		api.fda.gov
Good Doctors Co., Ltd.	Incheon Seoul, South Korea	Manufacturer	0		api.fda.gov
Guangdong Jinme Medical Technology Co., Ltd.	Foshan Guangdong, China	Manufacturer	0		api.fda.gov
Guangdong Launca Medical Device Technology Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0		api.fda.gov
Guangzhou Ajax Medical Equipment Co Ltd	Guangzhou Guangdong, China	Manufacturer	0		api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.	Guilin Guangxi, China	Manufacturer	0		api.fda.gov
GUILIN YIKESHI Medical Device CO LTD	Guilin Guangxi, China	Manufacturer	0		api.fda.gov
Hangzhou Chohotech Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		api.fda.gov
HDX Will Corp.	Heungdeok-gu, Cheongju-si, Chungcheongbuk-do Chungbuk, South Korea	Manufacturer	0		api.fda.gov
Hefei Meyer Optoelectronic Technology Inc.	Hefei Anhui, China	Manufacturer	0		api.fda.gov
Hunan Vsmile Biotechnology Co.,ltd	Changsha Hunan, China	Manufacturer	0		api.fda.gov
Huvitz Co., Ltd.	Anyang-si Gyeonggi, South Korea	Manufacturer	0		api.fda.gov
Iditec North West S.L.	TORRELODONES Madrid(Autonomous Community), Spain	Manufacturer	0		api.fda.gov
Ids Korea	Seoul, South Korea	Manufacturer	0		api.fda.gov
Imagoworks Inc.	Seoul, South Korea	Manufacturer	0		api.fda.gov
Inno3d Co., Ltd.	Seoul, South Korea	Manufacturer	0		api.fda.gov
Institut Straumann AG	BASEL Basel-Stadt, Switzerland	Specification developer	0		api.fda.gov
Inteware Co., Ltd	Chiayi County Chiayi(County), Taiwan	Manufacturer	0		api.fda.gov
JENOPTIK Optical Systems GmbH	Berlin, Germany	Contract manufacturer	0		api.fda.gov
Jiangsu Dynamic Medical Technology Co., Ltd	Suzhou Jiangsu, China	Exporter to the US, Manufacturer	0		api.fda.gov
Kavo Dental GMBH	WARTHAUSEN Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Konzelmann GMBH	Loechgau Baden-Wurttemberg, Germany	Contract manufacturer	0		api.fda.gov
Largev Instrument Corp., Ltd.	Beijing, China	Manufacturer	0		api.fda.gov
Manix Co., Ltd.	Anseong-si Gyeonggi, South Korea	Manufacturer	0		api.fda.gov
Manufacturera Dental Continental	ZAPOPAN Jalisco, Mexico	Complaint file establishment, Specification developer	0		api.fda.gov
Medit Corp.	Seoul, South Korea	Manufacturer	0		api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)	Daegu, South Korea	Specification developer	0		api.fda.gov
Megagen Implant Co., Ltd.	Daegu, South Korea	Manufacturer	0		api.fda.gov
Nam A Dental Medicine Company Limited	Thong Tay Hoi Ward Ho Chi Minh, Vietnam	Manufacturer	0		api.fda.gov
Nobel Biocare AB	GOTEBORG Vastra Gotaland, Sweden	Specification developer	0		api.fda.gov
Ningbo Runyes Medical Instrument Co., Ltd.	Ningbo Zhejiang, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Nobel Biocare Services AG	Kloten Zurich, Switzerland	Specification developer	0		api.fda.gov
Nobel Biocare c/o Medicim NV	Mechelen Antwerpen, Belgium	Complaint file establishment, Manufacturer	0		api.fda.gov
Ods Co., Ltd.	Incheon, South Korea	Manufacturer	0		api.fda.gov
One Day Dental Partner	Suncheon-si Jeonnam, South Korea	Exporter to the US, Manufacturer	0		api.fda.gov
Onvet Medical Canada Inc	TORONTO Ontario, Canada	Manufacturer	0		api.fda.gov
Ori Inc	Pleasant Grove, UT, United States	Manufacturer, Repackager or relabeler	0		api.fda.gov
Pac-Dent Inc.	Brea, CA, United States	Manufacturer	0		api.fda.gov
Prismatik Dentalcraft, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		api.fda.gov
Proto3000 Inc.	Vaughan Ontario, Canada	Manufacturer	0		api.fda.gov
Planmeca Oy	Helsinki Uusimaa, Finland	Manufacturer	0		api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		api.fda.gov
Primo Medical Group, Inc	W Bridgewater, MA, United States	Contract manufacturer	0		api.fda.gov
Ray Co., Ltd	Yongin-si Gyeonggi, South Korea	Exporter to the US, Manufacturer	0		api.fda.gov
Reko Dental, LLC	Gardena, CA, United States	Complaint file establishment, Specification developer	0		api.fda.gov
Shen Fu Arts Lab	Shen Zhen Guangdong, China	Manufacturer	0		api.fda.gov
Shenzhen Shuhe Technology Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Shenzhen Up3d Tech Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Shenzhen Yurucheng Dental Materials Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Sirona Dental Systems GMBH	BENSHEIM Hesse, Germany	Manufacturer, Specification developer	0		api.fda.gov
Smart Optics Sensortechnik GMBH	Bochum North Rhine-Westphalia, Germany	Manufacturer	0		api.fda.gov
Scan4all	LABEGE Haute-Garonne, France	Manufacturer	0		api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Shining 3D Tech Co.,Ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Straumann Manufacturing, Inc.	Mansfield, TX, United States	Contract manufacturer	0		api.fda.gov
Trident SRL	Castenedolo Brescia, Italy	Manufacturer	0		api.fda.gov
Tupel Ltd	Oxford Oxfordshire, United Kingdom	Manufacturer	0		api.fda.gov
Thanh Dental Laboratory	ho chi minh city, Vietnam	Contract manufacturer	0		api.fda.gov
X-Nav Technologies, LLC.	Lansdale, PA, United States	Complaint file establishment, Manufacturer	0		api.fda.gov
Zelia Dental Lab LLC	N Brunswick, NJ, United States	Manufacturer	0		api.fda.gov
Zirkonzahn SRL	Gais Bolzano, Italy	Manufacturer	0		api.fda.gov
Ziyang Freqty Medical Equipment Co., Ltd.	Ziyang Sichuan, China	Exporter to the US, Manufacturer	0		api.fda.gov
Zetta25 AG	Zurich, Switzerland	Manufacturer	0		api.fda.gov
etkon GMBH	Markkleeberg Saxony, Germany	Manufacturer	0		api.fda.gov
etkon GMBH	GRAEFELFING Bavaria, Germany	Manufacturer	0		api.fda.gov
iRay Group	Shanghai, China	Complaint file establishment, Manufacturer, Specification developer	0		api.fda.gov
iRay Imaging Technology Taicang Limited	Taicang Jiangsu, China	Contract manufacturer	0		api.fda.gov

Updated December 5, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.