Company · US

New Stetic

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (1 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
EBF	Material, Tooth Shade, Resin	1
EBG	Crown And Bridge, Temporary, Resin	1
EBI	Resin, Denture, Relining, Repairing, Rebasing	1
ELM	Denture, Plastic, Teeth	1
OIV	Dental Amalgam	1

Decided	510(k)	Device and applicant	Code
Mar 3, 2026	K254245	ZAFIRA® New Stetic, SA, CO	EBF
Nov 7, 2019	K192153	Portux CAD/CAM Disc New Stetic, SA, CO	EBG
Apr 29, 2014	K140125	NEW STETIC DENTAL AMALGAM ALLOY New Stetic	OIV
Feb 12, 2013	K122925	NEW STETIC ARTIFICIAL TEETH New Stetic	ELM
Mar 28, 2011	K102874	NEW STETIC ACRYLICS New Stetic	EBI

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.