Product Code: EJL FDA class 1 21 CFR 872.3240

Bur, Dental

Dental

The Dental Bur is a rotating cutting instrument with a cylindrical, round, or shaped head made of tungsten carbide or steel, mounted in a dental handpiece to remove tooth structure, prepare cavities, finish restorations, or cut bone during dental and oral surgical procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJL, regulated under 21 CFR 872.3240 in the Dental (DE) specialty.

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510(k)s

FEI Numbers

264

Registration Numbers

264

Unique Applicants

Years Active

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Basic Information

Product Code: EJL
Device Class: FDA class 1
Regulation Number: 872.3240
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K080687	SMARTBURS	Jun 20, 2008	Substantially Equivalent	S.S. White Burs, Inc.
K071352	CERADRILL	Jun 29, 2007	Substantially Equivalent	Gebr. Brasseler GmbH & Co. KG
K061383	BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS	Aug 03, 2006	Substantially Equivalent	B.T.I. Biotechnology Institute, Sl.
K943273	TRI HAWK BUR, FG BUR	Aug 01, 1994	Substantially Equivalent	Tri Hawk Corp.
K926205	MONOSTERYL	Feb 10, 1994	Substantially Equivalent	Utensili Super Abrasivi
K923883	DENTAL OR SURGICAL BUR	Jul 27, 1993	Substantially Equivalent	Stratum Dental Technologies, Inc.
K921406	SILICONT BUR BLOCK	Apr 28, 1992	Substantially Equivalent	Innovators, Inc.
K920243	SMART BURS TOTAL CARBIDES	Mar 25, 1992	Substantially Equivalent	Vermont Diamond Instruments
K911208	TIN COATED DENTAL BURS	Sep 16, 1991	Substantially Equivalent	Surgical Precision Instruments, Corp.
K910794	SMALL INSTRUMENT STERILIZATION/BUR BOX	May 23, 1991	Substantially Equivalent	Brevet, Inc.
K882183	DENTAL BURS	Jun 21, 1988	Substantially Equivalent	Tri-Stage, Inc.
K873698	STERILIZED DENTAL BIT PACKAGING	Dec 03, 1987	Substantially Equivalent	Florida Diamond Instruments Corp.
K863097	CB BUR	Aug 26, 1986	Substantially Equivalent	Beavers Dental, Div. Sybron Canada, Ltd.
K854691	DIAMOND BURS-HANDPIECE	Mar 25, 1986	Substantially Equivalent	Almore Intl., Inc.
K854690	DIAMONDS BURS-COMPOSIT FINISHING	Mar 25, 1986	Substantially Equivalent	Almore Intl., Inc.
K842720	BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL	May 21, 1985	Substantially Equivalent	Penn-Med Technology, Inc.
K833598	LEBLOND DIAMOND DENTAL BUR	Dec 29, 1983	Substantially Equivalent	A & M Instruments, Inc.
K823314	DENTAL INSTRUMENTS	Nov 24, 1982	Substantially Equivalent	Miltex, Inc.
K802989	MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.	Dec 30, 1980	Substantially Equivalent	Swiss American Metal Craft Corp.
K802988	JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS	Dec 30, 1980	Substantially Equivalent	Swiss American Metal Craft Corp.
K801886	BURR, DENTAL	Aug 20, 1980	Substantially Equivalent	Aesculap Instruments Corp.
K780641	DENTAL ROTARY CARBIDE BURS 76EJL	Apr 21, 1978	Substantially Equivalent	Teledyne Densco
K771347	R&R ALSTON CARBIDE BURS	Aug 03, 1977	Substantially Equivalent	Ransom and Randolph
K771214	SUPERFINE DIAMONDS	Jul 15, 1977	Substantially Equivalent	Den-Mat Corp.
K770469	CUTTER TUNGSTEN CARBIDE BURS	Mar 16, 1977	Substantially Equivalent	Cutter Laboratories, Inc.
K770093	DENTAL BURS	Jan 24, 1977	Substantially Equivalent	The S. S. White Co.
K760986	CARBIDE DENTAL BURS	Nov 15, 1976	Substantially Equivalent	Adp Intl., Inc.