New Stetic
GUARNE Antioquia, CO
NEW STETIC appears in FDA device records in GUARNE Antioquia, CO. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for New Stetic between 2011 and 2026. The busiest year on record is 2011, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2019 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254245 | ZAFIRA® | EBF | Substantially Equivalent | |
| K192153 | Portux CAD/CAM Disc | EBG | Substantially Equivalent | |
| K140125 | NEW STETIC DENTAL AMALGAM ALLOY | OIV | Substantially Equivalent | |
| K122925 | NEW STETIC ARTIFICIAL TEETH | ELM | Substantially Equivalent | |
| K102874 | NEW STETIC ACRYLICS | EBI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003794907 | 3003794907 | NEW STETIC | CARRERA 53, NO. 50-09, GUARNE Antioquia -- CO | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- NDPAccessories, Implant, Dental, Endosseous
- EJJAlloy, Amalgam
- EFNCotton, Roll
- EBGCrown And Bridge, Temporary, Resin
- OIVDental Amalgam
- ELMDenture, Plastic, Teeth
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- ELYMercury
- MQCMouthguard, Prescription
- EBIResin, Denture, Relining, Repairing, Rebasing
- EGDWax, Dental, Intraoral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain