Data / Medical devices / United States / Exocad America, Inc.

Exocad America, Inc.: FDA-registered device maker in Wakefield, MA, United States, 2 510(k) clearances

Name: Exocad America, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Exocad America, Inc. is registered with the FDA (registration 3013718526) in Wakefield, MA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 21, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013718526
Address: 301 Edgewater Pl Ste 330, Wakefield, MA, United States, 01880
Owner or operator: exocad GmbH (10055196)
Roles: Complaint file establishment
First device listed: June 19, 2017
Registered through: 2026
Brand names listed: AbutmentCAD, Ceramill Mind DRS, Ceramill Mind M-Plant, ChairsideCAD, DentalDB, Implant Module, PlanCAD Premium AbutmentCAD, exoplan

Devices it lists

Device	Product code	Class	Role	Source
Dental Abutment Design Software For Dental Laboratory	PNP	2	Complaint file establishment	accessdata.fda.gov
Medical Device Data System	OUG	1	Complaint file establishment	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 21, 2021	K193352	AbutmentCAD	PNP	Substantially Equivalent	Exocad GmbH	accessdata.fda.gov
August 6, 2019	K183458	exoplan 2.3	LLZ	Substantially Equivalent	Exocad GmbH	accessdata.fda.gov

Compare with other makers

Updated July 21, 2021. 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.