Zetta25 AG

FDA Device Registration & Listing · Zurich, CH · Registration 3029904428

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029904428
FEI Number
3029904428
Entity Name
Zetta25 AG
City/State/Country
Zurich, CH
Establishment Address
Albisriederstrasse 253, Zurich 8047, CH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DENTSPLY SIRONA INC (Owner Number: 2511302)
Owner / Operator Contact Address
221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250755
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2006-02-28
NTK Caries Detector, Laser Light, Transmission Dental Class 2 872.1745 2025-09-11
NBL Laser, Fluorescence Caries Detection Dental Class 2 872.1745 2025-09-11
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-08-13

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA INC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR
3003136642 OraMetrix GmbH Berlin Brandenburg, DE
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029904428. Last updated year: 2026. Please use registration number 3029904428 when referencing this establishment in official correspondence.
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