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

DZA — Predicate Candidate Screening

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

56 daysmedian FDA review time

233 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K984508	SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 98	W&H Dentalwerk Buermoos GmbH	1999-06-25	189
K962979	S-53 INTRORAL DENTAL SYSTEM	Del Medical Systems Corp.	1996-09-25	56
K954790	PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS	Tulsa Dental Products, Ltd.	1996-01-16	89
K914724	ADA SHANK EXTENSION	Implant Corp. of America	1993-07-27	648
K905418	GATES GLIDDEN DRILLS	The Hygenic Corp.	1991-07-25	233
K901097	FILLOCK REAMER	Ivoclar North America, Inc.	1990-04-25	49
K896149	ANEST-EZE DENTAL DRILL RA#2	Signature One Products, Inc.	1990-01-19	88
K884187	INDENTEC DRILL RA #1	Phillip C. Crawford, D.D.S.	1988-12-22	78
K811113	RIESS-LUHR	Allomedic	1981-06-16	54
K801888	HANDPIECE, DENTAL	Aesculap Instruments Corp.	1980-08-20	23
K801887	DRILL, DENTAL	Aesculap Instruments Corp.	1980-08-20	23
K761275	AIROTOS LF HANDPIECE	Dentsply Intl.	1976-12-23	3
K760956	SURGICAL MICRO DRILL	American Safety Equipment Corp.	1976-11-19	18

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