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

Dentalez Group · Predicate Candidate Screening

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

87 daysmedian FDA review time

324 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K030133	SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HAND	Dentalez Group	2003-04-29	105	0
K021378	PORTABLE HDX INTRAORAL X-RAY	Dentalez Group	2002-06-07	37	1
K990844	STARDENTAL AXCS STERILE WATER SYSTEM	Dentalez Group	1999-05-28	74	0
K983574	STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS	Dentalez Group	1999-01-08	87	0
K982593	LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WIT	Dentalez Group	1998-10-22	90	0
K960260	STAR TITAN SERIES MOTORS & ATTACHMENTS	Dentalez Group	1996-03-28	70	2
K960507	STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MID	Dentalez Group	1996-03-28	52	1
K960719	STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE	Dentalez Group	1996-03-28	36	1
K925567	E 4000 DENTAL OPERATING CHAIR	Dentalez Group	1994-03-10	492	0
K931093	QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE	Dentalez Group	1994-01-21	324	0
K902402	HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE	Dentalez Group	1990-08-29	90	0
K896361	HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE	Dentalez Group	1990-02-02	88	0
K881253	ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW	Dentalez Group	1988-04-21	29	2

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