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

Dentsply International — Predicate Candidate Screening

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

31 daysmedian FDA review time

114 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K122268	ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS	Dentsply International	2012-12-11	134
K061580	ECLIPSE WAX REMOVER	Dentsply International	2006-07-28	51
K060837	IN-OVATION C	Dentsply International	2006-04-10	13
K053368	INTERPROXIMAL REDUCTION SYSTEM	Dentsply International	2006-03-29	114
K052370	CP BRACKET SYSTEM	Dentsply International	2005-11-01	63
K052097	CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE	Dentsply International	2005-08-12	9
K050208	FRIADENT ESTHETICAP	Dentsply International	2005-06-14	137
K050959	DELTON ILLUMINATING PIT AND FISSURE SEALING	Dentsply International	2005-05-11	23
K050386	PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL A	Dentsply International	2005-02-23	8
K041372	SMARTLITE PS PEN-STYLE LED CURING LIGHT	Dentsply International	2004-06-24	31
K041343	XENO NM LIGHT CURED DENTAL ADHESIVE	Dentsply International	2004-06-16	27
K041335	PTM SYSTEM	Dentsply International	2004-06-16	29
K040144	QUIXX POSTERIOR RESTORATIVE	Dentsply International	2004-04-01	70
K033705	BOBCAT PRO SCALER SYSTEM, MODEL G-130	Dentsply International	2003-12-04	9
K032320	APPOLLO 3 ALLOY	Dentsply International	2003-10-01	65
K032319	CERA R PLUS ALLOY	Dentsply International	2003-09-30	64
K032318	MINERVA 58 ALLOY	Dentsply International	2003-09-30	64
K032321	CERA F ALLOY	Dentsply International	2003-09-30	64
K032851	ULTRACROWN 75 ALLOY	Dentsply International	2003-09-26	14
K031615	SLED CURING LIGHT SYSTEM	Dentsply International	2003-07-21	59
K030111	DIAMONDCOAT ULTRASONIC INSERTS	Dentsply International	2003-02-07	25
K023697	STERI-MATE STERILIZABLE HANDPIECE	Dentsply International	2002-11-06	2
K011009	WHITE MTA MATERIAL	Dentsply International	2001-05-02	28

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