Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003756493

FEI Number

3003756493

Entity Name

DENTSPLY INDUSTRIA E COMERCIO LTDA

City/State/Country

PIRASSUNUNGA Sao Paulo, BR

Establishment Address

RUA CARLOS TASSONI 4521, GALPAO 01, DISTRITO INDUSTRIAL, PIRASSUNUNGA Sao Paulo 13633-418, 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

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2008-01-16
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2019-05-23

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
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
9611053	VDW GMBH	MUNICH Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003756493. Last updated year: 2026. Please use registration number 3003756493 when referencing this establishment in official correspondence.