Exocad GmbH

Darmstadt Hesse, DE

EXOCAD GMBH appears in FDA device records in Darmstadt Hesse, DE. FDA records list 3 510(k) clearances between 2019-08-06 and 2022-05-03, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Exocad GmbH between 2019 and 2022. The busiest year on record is 2019, with 1. The most recent is 2022, with 1.

Clearances by year, as a table

510(k) clearance decisions for Exocad GmbH, by decision year
Year	Clearances
2019	1
2021	1
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K213302	exoplan	LLZ	Substantially Equivalent	2022-05-03
K193352	AbutmentCAD	PNP	Substantially Equivalent	2021-07-21
K183458	exoplan 2.3	LLZ	Substantially Equivalent	2019-08-06

Registered establishments

FDA registered establishments for Exocad GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011521456	3011521456	EXOCAD GMBH	Rosa-Parks-Str. 2, Darmstadt Hesse 64295 DE	2026	LLZ NOF OUG PNP

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2633-2023	exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.	A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a Step-by-Step Full Drill Protocol export implant library, exoplan software does not filter out unsupported sleeve height positions for a particular sub-full drill protocol and instead shows ALL possible sleeve height positions for all sub-full drill protocols. The use of an improper sleeve height position in a surgical guide could result in patient injury	Class II	2023-08-17	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain