Quantec Series 2000 Endodontic Files

Q: What is the product code of K962031?

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

FDA 510(k) K962031 · Tycom Dental

Substantially Equivalent

510(k) numberK962031

Submission

Device name: Quantec Series 2000 Endodontic Files
Applicant: Tycom Dental
Irvine, CA, US
Received: May 24, 1996
Decision date: June 4, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code EKS

510(k)	Device	Applicant	Decision
K062856	TF Rotary Nickel Titanium FileEKS · Traditional	Ormco Corp.	12/13/2006SE
K004031	NT Swift; Ti\Tec; Gates Glidden Drills; Dental Power Endodontic Hand FilesEKS · Traditional	Dental Power, Inc.	03/28/2001SE
K971319	NT Series Endodontic Files, Mac Series Endodontic FilesEKS · Traditional	Tycom Dental	05/22/1997SE
K970649	Hero 642EKS · Traditional	Micro-Mega	05/16/1997SE
K953604	Shaping Hedstrom N.T.EKS · Traditional	Sybron Dental Specialties, Inc.	09/28/1995SE
K935542	Nickel-Titanium K-Type FileEKS · Traditional	Union Broach, Div. Moyco Industries, Inc.	01/03/1994SE
K932529	Lightspeed Dental Hand InstrumentEKS · Traditional	Lightspeed Endodontics	11/04/1993SE
K933582	Profile Series 29 FilesEKS · Traditional	Tulsa Dental Products, Ltd.	10/20/1993SE
K902018	Dentaurum Ceramic Debonding UnitEKS · Traditional	Dentauraum, Inc.	04/03/1991SE
K905640	Solid Core Gutta Percha CarrierEKS · Traditional	The Hygenic Corp.	03/05/1991SE

More from The Hygenic Corp.

510(k)	Device	Decision
K971319	NT Series Endodontic Files, Mac Series Endodontic FilesEKS · Traditional	05/22/1997SE

Questions and answers

When was Quantec Series 2000 Endodontic Files cleared by the FDA?

Quantec Series 2000 Endodontic Files (K962031) received a 510(k) decision of Substantially Equivalent on June 4, 1996, 11 days after the submission was received.

What is the product code of K962031?

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