Device Atlas

Tri Hawk Bur, FG Bur

Q: What is the product code of K943273?

The FDA product code is EJL – Bur, Dental, a Class I (low risk) device regulated under 21 CFR 872.3240.

FDA 510(k) K943273 · Tri Hawk Corp.

Substantially Equivalent

510(k) numberK943273

Submission

Device name: Tri Hawk Bur, FG Bur
Applicant: Tri Hawk Corp.
Los Angeles, CA, US
Received: July 7, 1994
Decision date: August 1, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EJL – Bur, Dental
Device class: Class I (low risk)
Regulation: 21 CFR 872.3240
Specialty: Dental

Other 510(k)s with product code EJL

510(k)	Device	Applicant	Decision
K080687	SmartbursEJL · Traditional	S.S. White Burs, Inc.	06/20/2008SE
K071352	CeradrillEJL · Traditional	Gebr. Brasseler GmbH & Co. KG	06/29/2007SE
K061383	Bti Sterile Dental Drills Kit, Bti Abutments and CapsEJL · Traditional	B.T.I. Biotechnology Institute, Sl.	08/03/2006SE
K926205	MonosterylEJL · Traditional	Utensili Super Abrasivi	02/10/1994SE
K923883	Dental or Surgical BurEJL · Traditional	Stratum Dental Technologies, Inc.	07/27/1993SE
K921406	Silicont Bur BlockEJL · Traditional	Innovators, Inc.	04/28/1992SE
K920243	Smart Burs Total CarbidesEJL · Traditional	Vermont Diamond Instruments	03/25/1992SE
K911208	Tin Coated Dental BursEJL · Traditional	Surgical Precision Instruments, Corp.	09/16/1991SE
K910794	Small Instrument Sterilization/Bur BoxEJL · Traditional	Brevet, Inc.	05/23/1991SE
K882183	Dental BursEJL · Traditional	Tri-Stage, Inc.	06/21/1988SE

Questions and answers

When was Tri Hawk Bur, FG Bur cleared by the FDA?

Tri Hawk Bur, FG Bur (K943273) received a 510(k) decision of Substantially Equivalent on August 1, 1994, 25 days after the submission was received.

What is the product code of K943273?

The FDA product code is EJL – Bur, Dental, a Class I (low risk) device regulated under 21 CFR 872.3240.