Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

EJL · Predicate Candidate Screening

27 FDA 510(k) clearances under this product code; the 50 most recent screened below.

39 daysmedian FDA review time

312 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K080687	SMARTBURS	S.S. White Burs, Inc.	2008-06-20	101
K071352	CERADRILL	Gebr. Brasseler GmbH & Co. KG	2007-06-29	45
K061383	BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS	B.T.I. Biotechnology Institute, Sl.	2006-08-03	77
K943273	TRI HAWK BUR, FG BUR	Tri Hawk Corp.	1994-08-01	25
K926205	MONOSTERYL	Utensili Super Abrasivi	1994-02-10	428
K923883	DENTAL OR SURGICAL BUR	Stratum Dental Technologies, Inc.	1993-07-27	357
K921406	SILICONT BUR BLOCK	Innovators, Inc.	1992-04-28	39
K920243	SMART BURS TOTAL CARBIDES	Vermont Diamond Instruments	1992-03-25	68
K911208	TIN COATED DENTAL BURS	Surgical Precision Instruments, Corp.	1991-09-16	181
K910794	SMALL INSTRUMENT STERILIZATION/BUR BOX	Brevet, Inc.	1991-05-23	87
K882183	DENTAL BURS	Tri-Stage, Inc.	1988-06-21	28
K873698	STERILIZED DENTAL BIT PACKAGING	Florida Diamond Instruments Corp.	1987-12-03	80
K863097	CB BUR	Beavers Dental, Div. Sybron Canada, Ltd.	1986-08-26	12
K854690	DIAMONDS BURS-COMPOSIT FINISHING	Almore Intl., Inc.	1986-03-25	124
K854691	DIAMOND BURS-HANDPIECE	Almore Intl., Inc.	1986-03-25	124
K842720	BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL	Penn-Med Technology, Inc.	1985-05-21	312
K833598	LEBLOND DIAMOND DENTAL BUR	A & M Instruments, Inc.	1983-12-29	78
K823314	DENTAL INSTRUMENTS	Miltex, Inc.	1982-11-24	16
K802988	JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS	Swiss American Metal Craft Corp.	1980-12-30	39
K802989	MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.	Swiss American Metal Craft Corp.	1980-12-30	39
K801886	BURR, DENTAL	Aesculap Instruments Corp.	1980-08-20	23
K780641	DENTAL ROTARY CARBIDE BURS 76EJL	Teledyne Densco	1978-04-21	4
K771347	R&R ALSTON CARBIDE BURS	Ransom and Randolph	1977-08-03	14
K771214	SUPERFINE DIAMONDS	Den-Mat Corp.	1977-07-15	10
K770469	CUTTER TUNGSTEN CARBIDE BURS	Cutter Laboratories, Inc.	1977-03-16	6
K770093	DENTAL BURS	The S. S. White Co.	1977-01-24	7
K760986	CARBIDE DENTAL BURS	Adp Intl., Inc.	1976-11-15	25

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda