Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040288

FEI Number

3002806793

Entity Name

DENTSPLY INDUSTRIA E COMERCIO LTDA

City/State/Country

PIRASSUNUNGA Sao Paulo, BR

Establishment Address

RUA JOSE FRANCISCO DE SOUZA 1926, DISTRITO INDUSTRIAL, PIRASSUNUNGA Sao Paulo 13633-412, BR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Caulk Post & Core Kit Paper Points

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	1996-08-21
EKM	Gutta-Percha	Dental	Class 1	872.3850	1992-08-24

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

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3011554142	SHENZHEN DENCO MEDICAL CO., LTD.	Shenzhen Guangdong, CN
2086043	PAC-DENT INC.	Brea, CA, US
3012996495	VIARDEN LAB LLC	Mission, TX, US
2024312	Kerr Corporation	ORANGE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040288. Last updated year: 2026. Please use registration number 8040288 when referencing this establishment in official correspondence.