Manufacturer registered with FDA

Odne AG

Dübendorf, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10089937Specification developer1 clearance in five years

Device types listed: 4
Brands and models: 6
510(k) clearances: 12024–2024
Markets registered in: 1United States
Establishments: 1Switzerland

510(k) clearances per year, 2007–2026

Devices listed with FDA

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

Device type	Category	Role	Brands and models	Listed since
Dental Plastic Filling InstrumentEIY · Class 1	Dental hand instruments	Maker	OdneFill Tip	2024
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Maker	OdneCleanOdneClean Tip	2024
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	OdneFill	2024
Laser Activator for PolymerizationQNF · Class 2	—	Maker	OdneCureOdneCure Tip	2024

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 Odne AG as the applicant.

Decided	510(k)	Device	Device type
8 Aug 2024	K233844	OdneClean	ELC Ultrasonic Scaler

Also lists devices cleared under other names

Odne AG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Lumendo AG (2).

Decided	510(k)	Device	Applicant	Device type
2 Nov 2023	K232076	Fibercure	Lumendo AG	QNF Laser Activator for Polymerization
10 Jul 2023	K231387	Endofill	Lumendo AG	KIF Root Canal Filling Resin

Registered establishments

Establishment	Location	What it does
ODNE AGFDA reg. 3030405669	Dubendorf Zurich, Switzerland	Complaint file establishment, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10089937). 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.