CERAMIC PEDATRIC PREFORMED CROWN— 510(k) K091362

Substantially Equivalent

Ez-Pedo, Inc.

FDA 510(k) clearance K091362 for CERAMIC PEDATRIC PREFORMED CROWN, Substantially Equivalent on 2009-06-29. Applicant: Ez-Pedo, Inc.. Device class: 1.

Clearance details

Applicant: Ez-Pedo, Inc.
Product code: Code ELZ
Device class: Class 1
Regulation: 21 CFR 872.3330
Advisory panel: Dental
Date received: 2009-05-08
Decision date: 2009-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELZ

K932759 — TEMPOARY POLYCARBONATE CROWNS1994-07-22
K931352 — PEDO JACKETS OR PJ'S1993-07-21
K913152 — WHITER BITER CROWN1991-09-30
K912686 — WHITER BITER CROWN1991-09-16
K892893 — SDI POLYCARBONATE CROWN, SCHEIN'S1989-06-06

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