Dialysis, Jet System

FDA 510(k) K770331 · Janneck Ent. of Texas

Substantially Equivalent

510(k) numberK770331

Submission

Device name
Dialysis, Jet System
Applicant
Janneck Ent. of Texas
Mchenry, IL, US
Received
February 17, 1977
Decision date
April 20, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EKP – Reamer, Pulp Canal, Endodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EKP

510(k)DeviceApplicantDecision
K823686Reamer Type K EndodonticEKP · Traditional United Dental Mfg., Inc.12/28/1982SE
K822620Root Canal Reamers, Type KEKP · Traditional Union Broach, Div. Moyco Industries, Inc.09/28/1982SE
K800291Endex Reamers Pulp Canal, EndodonticEKP · Traditional Ipco Corp.02/19/1980SE
K770598Endodontic Instruments, R&R CutwellEKP · Traditional Ransom and Randolph04/05/1977SE
K770367Root Canal Files & ReamersEKP · Traditional Cemco Tool Co., Inc.03/01/1977SE

Questions and answers

When was Dialysis, Jet System cleared by the FDA?

Dialysis, Jet System (K770331) received a 510(k) decision of Substantially Equivalent on April 20, 1977, 62 days after the submission was received.

What is the product code of K770331?

The FDA product code is EKP – Reamer, Pulp Canal, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.