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

DZP — Predicate Candidate Screening

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

56 daysmedian FDA review time

151 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K120037	BLUWHITE DIAMOND DENTAL BURS MODIFIED	Beavers Dental, Div. Sybron Canada, Ltd.	2012-04-20	106
K943841	SOPHOS DENTAL DIAMOND	Sophos Technologic	1994-09-16	42
K940908	DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS	Dunhall Pharmaceuticals, Inc.	1994-08-29	186
K934981	DENTAL DRILL	Eare Consulting Service	1994-02-03	107
K923757	DENTAL DIAMOND DRILLS	Alpha Industrializacao DE Metais Ltda.	1993-03-16	231
K913651	MANI DIA-BURS	The Lahr Consulting Group, Inc.	1992-01-14	151
K901967	DENDIA WERK BURS AND CUTTING DISCS	Micro-Aire Surgical Instruments, Inc.	1990-07-13	73
K901262	F.G. LASER (DENTAL BUR)	Diamond Rotary and Carbide Intl.	1990-07-09	115
K900089	FG DIAMOND BURRS	Kab Gloves Unltd.	1990-04-03	88
K893844	3D DENTAL DIAMOND ROTARY INSTRUMENTS	Lustgarten Multi-Tech International, Inc.	1989-08-11	78
K885233	NOVA DIAMOND	Microcopy, Div. Neo-Flo, Inc.	1989-02-13	55
K880179	BEAVERS' DENTAL DIAMOND INSTRUMENTS	Beavers Dental, Div. Sybron Canada, Ltd.	1988-03-09	56
K871639	DENTAL DIAMOND BURS	E&D Dental Manufacturing Co.	1987-05-18	21
K854347	HYBRID POINTS	Shofu Dental Corp.	1985-12-27	59
K833038	SUMMA DISK	Shofu Dental Corp.	1983-10-04	28
K832856	GINGI CURETTAGE DIAMOND POINTS	Shofu Dental Corp.	1983-10-04	42
K832855	TPE DIAMOND POINTS	Shofu Dental Corp.	1983-09-29	37
K802984	MEISINGER DIAMOND DENTAL BURS	Swiss American Metal Craft Corp.	1980-12-30	39
K802987	JOTA DIAMOND DENTAL BURS	Swiss American Metal Craft Corp.	1980-12-30	39
K780864	DIAMOND STONES	Venture Technology, Inc.	1978-06-14	15
K760987	DIAMOND STONES	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