Data / Medical devices / Colombia / New Stetic
New Stetic: FDA-registered device maker in GUARNE Antioquia, Colombia, 5 510(k) clearances
New Stetic is registered with the FDA (registration 3003794907) in GUARNE Antioquia, Colombia. It lists 13 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 3, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003794907
- Address
- Carrera 53, No. 50-09, GUARNE Antioquia, Colombia, --
- Owner or operator
- NEW STETIC (9026802)
- Roles
- Manufacturer
- First device listed
- July 8, 2002
- Registered through
- 2027
- Brand names listed
- Alfa-Lux, BabyDent, Biodent, Colossus, Coral, Duracryl, Duratone-n, EZ-Cryl and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Alloy, Amalgam | EJJ | 2 | Manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Dental Amalgam | OIV | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Mercury | ELY | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | 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 3, 2026 | K254245 | ZAFIRA® | EBF | Substantially Equivalent | New Stetic, SA | accessdata.fda.gov |
| November 7, 2019 | K192153 | Portux CAD/CAM Disc | EBG | Substantially Equivalent | New Stetic, SA | accessdata.fda.gov |
| April 29, 2014 | K140125 | NEW STETIC DENTAL AMALGAM ALLOY | OIV | Substantially Equivalent | New Stetic | accessdata.fda.gov |
| March 28, 2011 | K102874 | NEW STETIC ACRYLICS | EBI | Substantially Equivalent | New Stetic | accessdata.fda.gov |
| May 27, 1993 | K931162 | KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH | ELM | Substantially Equivalent | King Dental Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Wax, Dental, Intraoral
- All makers of Denture, Plastic, Teeth
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated March 3, 2026. 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.