Jenker Needle Stick Protector

Q: What is the product code of K920758?

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

FDA 510(k) K920758 · Dentsply Intl.

Substantially Equivalent

510(k) numberK920758

Submission

Device name: Jenker Needle Stick Protector
Applicant: Dentsply Intl.
York, PA, US
Received: February 19, 1992
Decision date: April 28, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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)	Device	Applicant	Decision
K990511	X-Tip Intraosseous PerforatorDZM · Traditional	Schiff & Co.	04/27/1999SE
K914562	Aseptic Dental Tech. Total Treatment SystemDZM · Traditional	Aseptic Dental Technologies, Inc.	03/09/1992SE
K913573	Safety Plus Dental Injection NeedleDZM · Traditional	Specialites Septodont	11/07/1991SE
K910475	Dental Needle Protective SystemDZM · Traditional	Health Technology Systems, Inc.	09/13/1991SE
K910446	Stabident Local Anesthesia SystemDZM · Traditional	Fairfax Dental, Inc.	06/03/1991SE
K896219	Safe-T-Cap Needle CoverDZM · Traditional	Ausmedics Pty , Ltd.	01/22/1990SE
K894373	Nipro Dental NeedleDZM · Traditional	Pharma-Plast USA, Inc.	10/13/1989SE
K870921	Dental Needle (Cartridge Type)DZM · Traditional	Churchill Corp.	04/03/1987SE
K864970	Terumo Dental NeedlesDZM · Traditional	Terumo Medical Corp.	03/10/1987SE
K861150	Exel Dental NeedleDZM · Traditional	Exel Intl.	04/11/1986SE

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Questions and answers

When was Jenker Needle Stick Protector cleared by the FDA?

Jenker Needle Stick Protector (K920758) received a 510(k) decision of Substantially Equivalent on April 28, 1992, 69 days after the submission was received.

What is the product code of K920758?

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