Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004095674

FEI Number

3004095674

Entity Name

BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.

City/State/Country

SAO CARLOS Sao Paulo, BR

Establishment Address

RUA TEOTONIO VILELA 120, JARDIM TANGARA, SAO CARLOS Sao Paulo 13568-000, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA. (Owner Number: 2427609)

Owner / Operator Contact Address

RUA TEOTONIO VILELA 120, JARDIM TANGARA, SAO CARLOS, SAO PAULO, BR-SP 13568-000, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Plastvac P7 (Vacuum Forming Machine 110V) PlastPress (Positive Pressure Machine 110V) Magnifying Lenses 3,5x Magnifying Lenses 2,5x Thermoforming Material (Hard Crystal, PP Plate, Soft Opaque, Bicolor, Black, Blue, Green, Pink or White) Standard Facebow Elite Facebow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2007-05-31
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2012-05-30
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2020-03-11
KCR	Facebow	Dental	Class 1	872.3220	2012-01-17

Official Correspondent

MARIA ISABEL PICCIN

US Agent Details

Doram Elkayam Business: OBELIS USA LLC Email: regulatory@obelis.us Phone: (513) 7408559

Related Public Records

Same Entity

BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004095674. Last updated year: 2026. Please use registration number 3004095674 when referencing this establishment in official correspondence.