TRUETECH MEDICAL, INC. DENTURE CUPS— 510(k) K871160

Name: FDA 510(k) clearance K871160
Creator: U.S. Food and Drug Administration
Published: 1987-06-23

Substantially Equivalent

Zenex Medical, Inc.

FDA 510(k) clearance K871160 for TRUETECH MEDICAL, INC. DENTURE CUPS, Substantially Equivalent on 1987-06-23. Applicant: Zenex Medical, Inc.. Device class: 2.

Clearance details

Applicant: Zenex Medical, Inc.
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 1987-03-24
Decision date: 1987-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELM

view all

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 Zenex Medical, Inc.

view all

K864298 — ZENEX MEDICAL, INC. GAUZE SPONGES1986-12-04

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