FDA Registration
Active
🇧🇷 Brazil
BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.
Reg #: 3004095674
·
FEI: 3004095674
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.
- Registration Number
- 3004095674
- FEI Number
- 3004095674
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RUA TEOTONIO VILELA 120, JARDIM TANGARA
- City
- SAO CARLOS Sao Paulo
- Country
- BR
Owner / Operator
- Firm Name
- BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.
- Operator Number
- 2427609
- Address
- RUA TEOTONIO VILELA 120, JARDIM TANGARA
- City
- SAO CARLOS, SAO PAULO
- State
- BR-SP
- Postal Code
- 13568-000
- Country
- BR
- Correspondent
- MARIA ISABEL - PICCIN
US Agent
- Business Name
- OBELIS USA LLC
- Contact Name
- Doram Elkayam
- Address
- 8200 Beckett Park Dr Fl 1
- City
- West Chester
- State
- OH
- ZIP
- 45069
- Country
- US
- [email protected]
- Phone
- 513 7408559
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2007-05-31 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2012-05-30 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2020-03-11 |
| Facebow | KCR | Class 1 | Dental | No | 2012-01-17 |
| Articulators | EJP | Class 1 | Dental | No | 2003-07-15 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 2006-08-22 |
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
Articulator 4000-S
Articulator A7 Plus
Articulator Hanau Ulti-Mate
Microblaster Standard
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device