Manufacturer registered with FDA
New Stetic, SA
Guarne, Colombia. Lists 12 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 54
- 510(k) clearances
- 52011–2026
- Markets registered in
- 664 registrations outside the US
- Establishments
- 1Colombia
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name New Stetic, SA as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | New Stetic, SA | 5 clearances | 2011–2026 | Below |
| Colombia | INVIMA | Manufacturer | NEW STETIC S.A. | 34 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | NEW STETIC S.A. | 19 | 2017–2018 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NEW STETIC S.A. | 7 | 2000–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | NEW STETIC S.A. | 3 | 2024–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | NEW STETIC, S.A. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What New Stetic, SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | DuracrylEZ-CrylFidelityNovacrylNovacryl CNovacryl LO-CrylOpti-CrylPortux CAD/CAM DiscVeracril | 2011 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | DuracrylEZ-CrylFidelityNovacrylNovacryl CNovacryl LO-CrylOpti-CrylPortux CAD/CAM DiscVeracril | 2011 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Alfa-LuxBabyDentBiodentColossusCoralDuratone-nFidelityNewcrylNewcryl VNordent 10 moreOlympicOlympic PlusPortux 3D Printing Resin Try-InReflectionSplendidSteinVitSuper CT-RealTizianoUltradent | 2008 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Zafira | 2026 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Portux 3D Printing Resin BasicPortux 3D Printing Resin Model | 2025 |
| Roll CottonEFN · Class 1 | — | Maker | — | 2016 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Portux 3D Printing Resin Cast | 2025 |
| Amalgam AlloyEJJ · Class 2 | — | Maker | MicronicNU Alloy DPNu Alloy DP Active | 2014 |
| MercuryELY · Class 2 | — | Maker | MicronicNU Alloy DPNu Alloy DP Active | 2014 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | — | 2002 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Portux 3D Printing Resin SG | 2025 |
| Dental AmalgamOIV · Class 2 | — | Maker | MicronicNU Alloy DPNu Alloy DP Active | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names New Stetic, SA as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Mar 2026 | K254245 | ZAFIRA® | EBF Resin Tooth Shade Material |
| 7 Nov 2019 | K192153 | Portux CAD/CAM Disc | EBG Resin Temporary Crown and Bridge |
| 29 Apr 2014 | K140125 | NEW STETIC DENTAL AMALGAM ALLOY | OIV Dental Amalgam |
| 12 Feb 2013 | K122925 | NEW STETIC ARTIFICIAL TEETH | ELM Teeth Plastic Denture |
| 28 Mar 2011 | K102874 | NEW STETIC ACRYLICS | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Shofu Inc (1).
Also lists devices cleared under other names
New Stetic, SA lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: King Dental Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 May 1993 | K931162 | KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH | King Dental Corp. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEW STETICFDA reg. 3003794907 | GUARNE Antioquia, Colombia | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9026802). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.