Data / Medical devices / Mexico / Border Assembly S. de R.L de C.V.
Border Assembly S. de R.L de C.V.: FDA-registered device maker in Tijuana Baja California, Mexico, 2 510(k) clearances
Border Assembly S. de R.L de C.V. is registered with the FDA (registration 3023401336) in Tijuana Baja California, Mexico. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 9, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023401336
- Address
- Andador Arsenio Otanez 12502 Col. El Realito, Tijuana Baja California, Mexico, 22250
- Owner or operator
- Candid Care Co. (10055632)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- November 10, 2018
- Registered through
- 2026
- Brand names listed
- Candid Aligner, Candid Aligner Kit FGS-0001, FGS-0002; Candid Care Replacement Kit FGS-0004; Candid Care Refinement Kit FGS-0008, Candid Care Retainer, Candid Care Retainer Kit FGS-0003, Candid Cheek Retractor, Candid Clear Aligner, FGS-0003 PermaForm Retainer, FGS-0005 Whitening Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oral Irrigation Kit | OGT | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | 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 9, 2019 | K190948 | Magic Clear Aligners | NXC | Substantially Equivalent | Voodoo Manufacturing, Inc. | accessdata.fda.gov |
| September 8, 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor, All Types
- All makers of Aligner, Sequential
- All makers of Material, Impression
- All makers of Oral Irrigation Kit
- All makers of Maintainer, Space Preformed, Orthodontic
Updated May 9, 2019. 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.