Device Atlas

Endodontic BROACH(76EKN) Barbed Broach

Q: What is the product code of K831749?

The FDA product code is EKW – Broach, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.

FDA 510(k) K831749 · Union Branch

Substantially Equivalent

510(k) numberK831749

Submission

Device name: Endodontic BROACH(76EKN) Barbed Broach
Applicant: Union Branch
Mchenry, IL, US
Received: May 23, 1983
Decision date: July 12, 1983
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: EKW – Broach, Endodontic
Device class: Class I (low risk)
Regulation: 21 CFR 872.4565
Specialty: Dental

Other 510(k)s with product code EKW

510(k)	Device	Applicant	Decision
K871493	Denti-Tray(Tm)EKW · Traditional	Advanced Medical, Inc.	06/24/1987SE
K870765	Cannulated Instrument CleanersEKW · Traditional	Treace Medical, Inc.	05/27/1987SE
K862523	Man Surg Instr/Access Dumbach Titan Mesh Impl SysEKW · Traditional	Walter Lorenz Surgical, Inc.	08/01/1986SE
K823489	Endodontic Broach-Barbed BroachEKW · Traditional	Union Broach, Div. Moyco Industries, Inc.	12/15/1982SE
K800292	Endex Broach, EndodonticEKW · Traditional	Ipco Corp.	02/19/1980SE
K760985	Hand InstrumentsEKW · Traditional	Adp Intl., Inc.	11/15/1976SE

More from Adp Intl., Inc.

510(k)	Device	Decision
K831748	Endodontic Root Canal Plugger Finger-EKR · Traditional	07/12/1983SE

Questions and answers

When was Endodontic BROACH(76EKN) Barbed Broach cleared by the FDA?

Endodontic BROACH(76EKN) Barbed Broach (K831749) received a 510(k) decision of Substantially Equivalent on July 12, 1983, 50 days after the submission was received.

What is the product code of K831749?

The FDA product code is EKW – Broach, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.