# New Stetic

- Location (FDA's records): Apollo Beach, FL
- FDA decisions: 5 (2011–2026): 5 510(k) clearances
- Names in FDA's records: New Stetic (3); New Stetic, SA (2)
- Product codes: ELM (1), OIV (1), EBF (1), EBI (1), EBG (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- King Dental Corp.: 1 (https://510kreport.com/company/king-dental)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Sybron Corp.: 1 (https://510kreport.com/company/sybron)
- Johnson & Johnson Professionals, Inc.: 1 (https://510kreport.com/company/johnson-johnson-professionals)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)
- Austenal, Inc.: 1 (https://510kreport.com/company/austenal)
- Harvest Dental Products, LLC: 1 (https://510kreport.com/company/harvest-dental-products)

## Firms that cite its devices most
- Nuxen S.R.L.: 1 (https://510kreport.com/company/nuxen)
- Pro3Dure Medical GmbH: 1 (https://510kreport.com/company/pro3dure-medical)
- Yamahachi Dental Manufacturing Co.: 1 (https://510kreport.com/company/yamahachi-dental-manufacturing)

## Its most-cited devices
- K102874: New Stetic Acrylics (2011), cited by 2
- K192153: Portux CAD/CAM Disc (2019), cited by 1

## Recent decisions
- K254245: Zafira® (Mar 3, 2026)
- K192153: Portux CAD/CAM Disc (Nov 7, 2019)
- K140125: New Stetic Dental Amalgam Alloy (Apr 29, 2014)
- K122925: New Stetic Artificial Teeth (Feb 12, 2013)
- K102874: New Stetic Acrylics (Mar 28, 2011)

Source page: https://510kreport.com/company/new-stetic