Hydro Print Premium Fast Set

by Vigodent Indústria e Comércio Ltda

Ref 052037Model Alginato Odontológico para Moldagem510(k) K253501

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253501↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number78978083ALG35863ZF Basic UDI-DI 07897808336652UDI-DI	Date11 Feb 2026Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK253501	Date31 Oct 2025Cleared	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name: Alginato Odontológico Premium – Hydro Print / Chroma Print / Ezact Kromm
Model / Reference: Alginato Odontológico para Moldagem, 052037

Primary DI / UDI-DI: 07897808336652
Basic UDI-DI: 78978083ALG35863ZF
510(k) Number: K253501
FDA Product Code: ELW
EMDN Code: Q01020101 Dental impression alginates

Device Class: Class I EUDAMED
Class II 510(k)
Regulation: 21 CFR Part 872.3660
EU market of registration: Türkiye
Advisory Committee: Dental
FDA Decision: SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	510(k)
Device Class	EUDAMED Class I	510(k) Class II

Manufacturer details

EUDAMED SRN: BR-MF-000051955
Authorised representative: Obelis s.a. BE-AR-000000106

Other devices from Vigodent Indústria e Comércio Ltda

Hydro Print Premium Regular Set

Class I
Ezact Kromm

Class I
Chromaprint Premium Regular Set

Class I
Chroma Print Premium Fast Set

Class I

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No