OBTURATION GUTTA— 510(k) K822464

Substantially Equivalent

U.S. Shizai Corp.

FDA 510(k) clearance K822464 for OBTURATION GUTTA, Substantially Equivalent on 1982-11-03. Applicant: U.S. Shizai Corp.. Device class: 1.

Clearance details

Applicant: U.S. Shizai Corp.
Product code: Code EKA
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1982-08-16
Decision date: 1982-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKA

K830764 — FR ROOT CANAL SEALER1983-07-26

More clearances from U.S. Shizai Corp.

K853841 — HARMO SONIC1986-02-04
K820639 — OBTURATION SYSTEM KIT1982-04-09
K802189 — DENTLOID1980-09-26
K800951 — CASTA-LLOY1980-05-08

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