Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030405669

FEI Number

3030405669

Entity Name

ODNE AG

City/State/Country

Dubendorf Zurich, CH

Establishment Address

Ringstrasse 14, Dubendorf Zurich 8600, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Odne AG (Owner Number: 10089937)

Owner / Operator Contact Address

Ringstrasse 14, Dübendorf, CH-ZH 8600, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OdneFill OdneCure OdneCure Tip OdneClean Tip OdneClean OdneFill Tip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-01-24
QNF	Laser Activator For Polymerization	Dental	Class 2	872.6070	2024-01-24
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2024-08-12
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2024-01-24

Official Correspondent

Mark Bispinghoff

US Agent Details

Andreas Schmocker Business: Odne Inc Email: andreas.schmocker@odne.co Phone: (303) 9440201

Related Public Records

Same Entity

Odne AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06

Similar Registrations

Registration Number	Establishment Name	Location
3003449480	VERICOM CO., LTD.	Chuncheon-Si Gangwon, KR
3031606505	ENPUNO BIOTECHNOLOGY CO., LTD	Changsha Hunan, CN
3006542438	ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS	LONDRINA Parana, BR
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
9610964	SEPTODONT	CEDEX Val-de-Marne, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030405669. Last updated year: 2026. Please use registration number 3030405669 when referencing this establishment in official correspondence.