Data / Medical devices / Brazil / Implacil De Bortoli Material Odontologico Ltda
Implacil De Bortoli Material Odontologico Ltda: FDA-registered device maker in Sao Paulo, Brazil, 2 510(k) clearances
Implacil De Bortoli Material Odontologico Ltda is registered with the FDA (registration 3015775866) in Sao Paulo, Brazil. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015775866
- Address
- Rua Vicente De Carvalho, Sao Paulo, Brazil, 01521020
- Owner or operator
- IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA (10061070)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 9, 2019
- Registered through
- 2026
- Brand names listed
- Abutment, Implant, Dental, Endosseous - Implacil Implant System, Accessories, Implant, Dental, Endosseous - Accessories, Implant, Dental, Endosseous, Implacil Implant System, Implant, Endosseous, Root-Form - Implacil Implant System, Tray, Surgical, Instrument - Tray, Surgical, Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2021 | K202832 | Implacil Implant System | DZE | Substantially Equivalent | Implacil DE Bortoli Material Odontologico Ltda | accessdata.fda.gov |
| February 13, 2020 | K183024 | Implacil Implant System | DZE | Substantially Equivalent | Implacil DE Bortoli Material Odontologico Ltda | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Tray, Surgical, Instrument
Updated May 26, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.