Manufacturer registered with FDA

ReOss GmbH

Filderstadt, Germany. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10078409Manufacturer

Device types listed: 2
Brands and models: 1
510(k) clearances: 12020–2020
Markets registered in: 1United States
Establishments: 1Germany

510(k) clearances per year, 2007–2026

Devices listed with FDA

What ReOss GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Bone PlateJEY · Class 2	Maxillofacial plates & screws	Maker	Yxoss	2020
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	—	2022

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

510(k) clearances

Clearances on which FDA names ReOss GmbH as the applicant.

Decided	510(k)	Device	Device type
17 Jun 2020	K192747	Yxoss CBR®	JEY Bone Plate

Registered establishments

Establishment	Location	What it does
REOSS GMBHFDA reg. 3017734069	Filderstadt Baden-Wurttemberg, Germany	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10078409). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.