Data / Medical devices / Mexico / Ortotec De BC MX SA De CV
Ortotec De BC MX SA De CV: FDA-registered device maker in Tecate Baja California, Mexico, 2 510(k) clearances
Ortotec De BC MX SA De CV is registered with the FDA (registration 3011788941) in Tecate Baja California, Mexico. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 19, 2013. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011788941
- Address
- Benito Juarez No. 751, Tecate Baja California, Mexico, 21440
- Owner or operator
- MPL MANUFACTURING INC (10054003)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 31, 2017
- Registered through
- 2026
- Brand names listed
- Metal Band, Metal Bracket
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Preformed, Orthodontic | ECM | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Plastic, Orthodontic | DYW | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 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 |
|---|---|---|---|---|---|---|
| December 19, 2013 | K132368 | VAPOR CERAMIC BRACKET | NJM | Substantially Equivalent | Orthodontic Design and Production, Inc. | accessdata.fda.gov |
| November 21, 1997 | K973776 | REFLECTIONS | DYW | Substantially Equivalent | Cdb Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Orthodontic
- All makers of Bracket, Metal, Orthodontic
- All makers of Bracket, Plastic, Orthodontic
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Band, Preformed, Orthodontic
- All makers of Wire, Orthodontic
Updated December 19, 2013. 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.