Dental Needle Protective System

FDA 510(k) K910475 · Health Technology Systems, Inc.

Substantially Equivalent

510(k) numberK910475

Submission

Device name
Dental Needle Protective System
Applicant
Health Technology Systems, Inc.
Lexington, KY, US
Received
February 6, 1991
Decision date
September 13, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DZM – Needle, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4730
Specialty
Dental

Other 510(k)s with product code DZM

510(k)DeviceApplicantDecision
K990511X-Tip Intraosseous PerforatorDZM · Traditional Schiff & Co.04/27/1999SE
K920758Jenker Needle Stick ProtectorDZM · Traditional Dentsply Intl.04/28/1992SE
K914562Aseptic Dental Tech. Total Treatment SystemDZM · Traditional Aseptic Dental Technologies, Inc.03/09/1992SE
K913573Safety Plus Dental Injection NeedleDZM · Traditional Specialites Septodont11/07/1991SE
K910446Stabident Local Anesthesia SystemDZM · Traditional Fairfax Dental, Inc.06/03/1991SE
K896219Safe-T-Cap Needle CoverDZM · Traditional Ausmedics Pty , Ltd.01/22/1990SE
K894373Nipro Dental NeedleDZM · Traditional Pharma-Plast USA, Inc.10/13/1989SE
K870921Dental Needle (Cartridge Type)DZM · Traditional Churchill Corp.04/03/1987SE
K864970Terumo Dental NeedlesDZM · Traditional Terumo Medical Corp.03/10/1987SE
K861150Exel Dental NeedleDZM · Traditional Exel Intl.04/11/1986SE

Questions and answers

When was Dental Needle Protective System cleared by the FDA?

Dental Needle Protective System (K910475) received a 510(k) decision of Substantially Equivalent on September 13, 1991, 219 days after the submission was received.

What is the product code of K910475?

The FDA product code is DZM – Needle, Dental, a Class I (low risk) device regulated under 21 CFR 872.4730.