NEW STETIC ARTIFICIAL TEETH— 510(k) K122925

Substantially Equivalent

New Stetic

FDA 510(k) clearance K122925 for NEW STETIC ARTIFICIAL TEETH, Substantially Equivalent on 2013-02-12. Applicant: New Stetic. Device class: 2.

Clearance details

Applicant: New Stetic
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2012-09-24
Decision date: 2013-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELM

K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S2014-01-14
K122955 — DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM2013-03-01
K122852 — PHYSIOSTAR NFC2012-12-06
K121749 — VERACIA2012-09-07
K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH2012-05-21

More clearances from New Stetic

K140125 — NEW STETIC DENTAL AMALGAM ALLOY2014-04-29
K102874 — NEW STETIC ACRYLICS2011-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.