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

DYN — Predicate Candidate Screening

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

55 daysmedian FDA review time

180 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K940769	DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR	Terraflex	1994-08-17	180
K935758	HYGOFLEX SALIVA-EJECTOR	J.H.Orsing AB	1994-03-21	115
K935616	SALIVA EJECTOR DISPOSABLE	Asa Instruments S.R.L.	1994-03-21	119
K924211	EJECTOR	Glenroe Technologies	1993-03-31	223
K920492	HIGH VAC	Hygoplastic, Inc.	1992-05-11	98
K921117	MINIDAM	Delsan Dental Systems	1992-05-05	57
K900631	SALIVA ABSORBER - DENTAL	Kab Gloves Unltd.	1990-04-04	55
K871315	ORAL ASPIRATOR	Endovations	1987-04-15	14
K870599	TIP, DENTAL SUCTION APPARATUS	Military Engineering, Inc.	1987-03-23	41
K864300	SILIVA EJECTOR/ORAL CAVITY EVACUATOR	Ardent Intl., Inc.	1986-11-24	24
K863768	SALIVA EJECTORS	The Medical Group, Inc.	1986-10-27	32
K863163	ULS 8-86	American Instrument Manufacturer'S, Inc.	1986-09-22	35
K861934	SALIVA EJECTOR	Carlisle Laboratories, Inc.	1986-06-09	20
K801927	SILENTSLEEP	Slumber Research, Inc.	1980-11-14	94
K800210	TONGUE HOLDER/SALIVA EJECTOR	Unitek Corp.	1980-02-06	5
K781592	SURGICAL ASPIRATOR TIPS	Henry Schein, Inc.	1978-12-04	77
K761264	OPTIONS FOR STAR DENTAL OPUS I	Syntex Corp.	1976-12-23	7
K760620	SALIVA EJECTOR	Lorvic Corp.	1976-09-21	8

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