Device Atlas

Detectar, Model N123-MI

Q: What is the product code of K023367?

The FDA product code is EJB – Handle, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.

FDA 510(k) K023367 · Neks Technologies

Substantially Equivalent

510(k) numberK023367

Submission

Device name: Detectar, Model N123-MI
Applicant: Neks Technologies
Chapel Hill, NC, US
Received: October 8, 2002
Decision date: June 25, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EJB – Handle, Instrument, Dental
Device class: Class I (low risk)
Regulation: 21 CFR 872.4565
Specialty: Dental

Other 510(k)s with product code EJB

510(k)	Device	Applicant	Decision
K140144	Benda WedgeEJB · Traditional	Centrix, Inc.	07/08/2014SE
K981234	Flare,File, FillEJB · Traditional	Lone Star Technologies	06/05/1998SE
K930094	AukusleeveEJB · Traditional	Aukland Medical Plastics, Inc.	10/20/1993SE
K922633	Cavi-ZymeEJB · Traditional	E&D Dental Products, Inc.	08/06/1992SE
K871818	Spatula, Dental, CementEJB · Traditional	Military Engineering, Inc.	07/02/1987SE
K833338	Tooth SloothEJB · Traditional	Joel Lander D.D.S.	11/25/1983SE
K823913	Soft Grip Uni-HandleEJB · Traditional	Treace Medical, Inc.	01/26/1983SE

More from Treace Medical, Inc.

510(k)	Device	Decision
K063321	D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138NBL · Traditional	03/30/2007SE
K043156	D-Carie, Model N121-M1NBL · Traditional	04/28/2005SE

Questions and answers

When was Detectar, Model N123-MI cleared by the FDA?

Detectar, Model N123-MI (K023367) received a 510(k) decision of Substantially Equivalent on June 25, 2003, 260 days after the submission was received.

What is the product code of K023367?

The FDA product code is EJB – Handle, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.