Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042158426

FEI Number

3042158426

Entity Name

INCI DENTAL TIBBI MALZEME SANAYI VE TICARET LIMITED SIRKETI

City/State/Country

Istanbul, TR

Establishment Address

Defterdat Mah Otakcilar Cad E Blok Sit No 74 4, Eyupsultan, Istanbul 34050, TR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INCI DENTAL TIBBI MALZEME SANAYI VE TICARET LIMITED SIRKETI (Owner Number: 10094302)

Owner / Operator Contact Address

Defterdat Mah Otakcilar Cad E Blok Sit No 74 4, Eyupsultan, Istanbul, TR-NOTA 34050, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2025-11-21

Official Correspondent

Mustafa Demir

US Agent Details

Sunita Mehta Business: Sonendo Inc. Email: smehta@sonendo.com Phone: (949) 7663636

Related Public Records

Same Entity

INCI DENTAL TIBBI MALZEME SANAYI VE TICARET LIMITED SIRKETI

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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Similar Registrations

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1215305	PULPDENT CORPORATION	Watertown, MA, US
3007284437	ORTHO ARCH COMPANY INC	Schaumburg, IL, US
2437780	CARGUS INT'L, INC.	CONGERS, NY, US
3009431661	SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042158426. Last updated year: 2026. Please use registration number 3042158426 when referencing this establishment in official correspondence.