Stabident Local Anesthesia System

FDA 510(k) K910446 · Fairfax Dental, Inc.

Substantially Equivalent

510(k) numberK910446

Submission

Device name
Stabident Local Anesthesia System
Applicant
Fairfax Dental, Inc.
Miami, FL, US
Received
January 14, 1991
Decision date
June 3, 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
K910475Dental Needle Protective SystemDZM · Traditional Health Technology Systems, Inc.09/13/1991SE
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 Stabident Local Anesthesia System cleared by the FDA?

Stabident Local Anesthesia System (K910446) received a 510(k) decision of Substantially Equivalent on June 3, 1991, 140 days after the submission was received.

What is the product code of K910446?

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