WIEDENT ESTETIC— 510(k) K061337

Substantially Equivalent

Xpdent Corp

FDA 510(k) clearance K061337 for WIEDENT ESTETIC, Substantially Equivalent on 2006-06-07. Applicant: Xpdent Corp. Device class: 2.

Clearance details

Applicant: Xpdent Corp
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2006-05-12
Decision date: 2006-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, 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
K122925 — NEW STETIC ARTIFICIAL TEETH2013-02-12
K122852 — PHYSIOSTAR NFC2012-12-06
K121749 — VERACIA2012-09-07

More clearances from Xpdent Corp

K082158 — DENSEO FAIRY2008-10-15
K071201 — ZEO CE LIGHT & ZEO QUICK PORCELAIN2007-07-30

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