Data / Medical devices / Mexico / Ormex S. de R.L. de C.V.
Ormex S. de R.L. de C.V.: FDA-registered device maker in Yucatan Uman, Mexico, 2 510(k) clearances
Ormex S. de R.L. de C.V. is registered with the FDA (registration 8030637) in Yucatan Uman, Mexico. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 11, 1996. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8030637
- FEI number
- 3002807826
- Address
- CALLE 21, No. 1103, AMPLIACION CIUDAD IND., Yucatan Uman, Mexico, 97390
- Owner or operator
- SYBRON DENTAL SPECIALTIES, INC. (9029565)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 12, 1993
- Registered through
- 2027
- Brand names listed
- AlgiNot, All Ceramic Logic Set, All-Purpose Esthetic Logic Set, Anterior Composite Logic Set, Autofit Backfill Gutta Percha, Autofit Gutta Percha, Axial Reduction - MADC, Axial Reduction Logic Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Metal, Orthodontic | EJF | 1 | Contract manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Contract manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Contract manufacturer | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Contract manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Contract manufacturer | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Contract manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Contract manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 11, 1996 | K955932 | EXAFLEX IMPRESSION MATERIAL (MODIFICATION) | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 14, 1981 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Dental-Material Gesellschaft | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Diamond, Dental
- All makers of Material, Impression
- All makers of File, Pulp Canal, Endodontic
- All makers of Gutta-Percha
- All makers of Spreader, Pulp Canal Filling Material, Endodontic
- All makers of Bur, Dental
Updated March 11, 1996. 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.