Cleared Traditional

K770331 - DIALYSIS, JET SYSTEM
(FDA 510(k) Clearance)

K770331 · Janneck Ent. of Texas · Dental device

Apr 1977

Decision

62d

Days

Class 1

Risk

K770331 is an FDA 510(k) clearance for the DIALYSIS, JET SYSTEM. This device is classified as a Reamer, Pulp Canal, Endodontic (Class I - General Controls, product code EKP).

Submitted by Janneck Ent. of Texas (Mchenry, US). The FDA issued a Cleared decision on April 20, 1977, 62 days after receiving the submission on February 17, 1977.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K770331 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 17, 1977
Decision Date	April 20, 1977
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—