Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003548115

FEI Number

3003548115

Entity Name

OLSEN INDUSTRIA E COMERCIO S/A

City/State/Country

Palhoca Santa Catarina, BR

Establishment Address

Avenida Ivo Lucchi, 68, Jardim Eldorado, Palhoca Santa Catarina 88133-510, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OLSEN INDUSTRIA E COMERCIO S/A (Owner Number: 10042326)

Owner / Operator Contact Address

Avenida Ivo Lucchi, 68, Jardim Eldorado, Palhoca, BR-SC 88133-510, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180935

PMA Number

N/A

All Registered Proprietary Names

CHAIR, DENTAL, WITHOUT OPERATIVE UNIT LIGHT, OPERATING, DENTAL TABLE, EXAMINATION, MEDICAL, POWERED TABLE, POWERED Controller, foot, handpiece and cordUnit, operative dental

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2021-11-12
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2022-05-03
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2012-11-14
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2013-07-10
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2020-02-11
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2020-02-11

Official Correspondent

No official correspondent registered.

US Agent Details

Lilian Llull Business: Techlink International LLC Email: lilian@techlinkusa.net Phone: (305) 2066777

Related Public Records

Same Entity

OLSEN INDUSTRIA E COMERCIO S/A

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
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21

Similar Registrations

Registration Number	Establishment Name	Location
3005082946	HALLIM POINT IMPLANT CO., LTD	SIHEUNG-SI Gyeonggi, KR
3039246551	SUMMIT DENTAL SYSTEMS LLC.	Fort Lauderdale, FL, US
3038285060	GREATCARE 4U SDN BHD	Selangor Darul Ehsan, MY
3025414363	TIANJIN WATER SOURCE TECH CO., LTD.	Tianjin, CN
3017604	ASEPTICO, INC.	WOODINVILLE, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003548115. Last updated year: 2026. Please use registration number 3003548115 when referencing this establishment in official correspondence.