SUN MEDICAL CO., LTD.

FDA Device Registration & Listing · Moriyama Shiga, JP · Registration 8030419

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
8030419
FEI Number
3002973484
Entity Name
SUN MEDICAL CO., LTD.
City/State/Country
Moriyama Shiga, JP
Establishment Address
571-2 Furutaka-cho, Moriyama Shiga 524-0044, JP
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
SUN MEDICAL CO., LTD. (Owner Number: 10094760)
Owner / Operator Contact Address
571-2 Furutaka-cho, Moriyama, JP-25 524-0044, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K254063
PMA Number
N/A

All Registered Proprietary Names

iCEM Universal Plus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EMA Cement, Dental Dental Class 2 872.3275 2025-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Vincent Email: david.vincent@kulzer-dental.com Phone: (574) 2995421

Related Public Records

Same Entity

SUN MEDICAL CO., LTD.
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
K254063 Kulzer, LLC iCEM Universal Plus 2025-12-19
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030419. Last updated year: 2026. Please use registration number 8030419 when referencing this establishment in official correspondence.
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