Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044854077

FEI Number

3044854077

Entity Name

HYDRORAL SAS

City/State/Country

Acigne Bretagne, FR

Establishment Address

8 rue du Fort de la Motte, Acigne Bretagne 35690, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HydrOral SAS (Owner Number: 10095710)

Owner / Operator Contact Address

8 rue du Fort de la Motte, Acigné, FR-BRE 35690, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydroral PDA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2026-04-20

Official Correspondent

Matt Ciesicki

US Agent Details

Olli-Pekka Lumijarvi Business: HydrOral Email: op.lumijarvi@hydroral.com Phone: (617) 8335592

Related Public Records

Same Entity

HydrOral SAS

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044854077. Last updated year: 2026. Please use registration number 3044854077 when referencing this establishment in official correspondence.