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

Pulpdent Corporation — Predicate Candidate Screening

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

79 daysmedian FDA review time

144 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days
K210045	ACTIVA PRESTO PACK	Pulpdent Corporation	2021-09-22	257
K173020	OBA-MCP, Orthodontic Bracket Adhesive with MCP	Pulpdent Corporation	2018-01-17	111
K172169	Pulpdent (Activa) Pit and Fissure Sealant with MCP	Pulpdent Corporation	2018-01-05	171
K153249	Pulpdent Solo Flowable Composite with MCP	Pulpdent Corporation	2016-04-01	144
K130223	RMGI FILL	Pulpdent Corporation	2013-03-29	59
K123265	RMGI LOW VISCOSITY	Pulpdent Corporation	2012-12-07	49
K120784	TUFF-TEMP 2.0	Pulpdent Corporation	2012-06-08	85
K120003	NUCAL	Pulpdent Corporation	2012-04-05	93
K120213	ETCH-RITE SUPREME	Pulpdent Corporation	2012-03-30	66
K113818	EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL	Pulpdent Corporation	2012-03-21	85
K113711	LIME-LITE II	Pulpdent Corporation	2012-03-05	77
K113617	SPEE-DEE PATCH	Pulpdent Corporation	2012-03-02	86
K112946	ACTIV VARNISH	Pulpdent Corporation	2011-12-09	66
K100503	PULPDENT COPAL VARNISH WITH FLUORIDE	Pulpdent Corporation	2010-05-12	79
K093620	PULPDENT FLUORIDE VARNISH	Pulpdent Corporation	2010-03-10	107
K090457	ORALUBE	Pulpdent Corporation	2009-05-21	87
K090391	PULPDENT MICRO-HYBRID COMPOSITE	Pulpdent Corporation	2009-05-11	83
K081810	PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL	Pulpdent Corporation	2008-09-17	83
K071278	EMBRACE DUAL CURE COMPOSITE MATERIALS	Pulpdent Corporation	2007-06-29	53
K052281	EMBRACE WETBOND CLEAR SEALANT	Pulpdent Corporation	2006-02-08	170
K040236	PULPDENT VLC RESIN CEMENT	Pulpdent Corporation	2004-04-20	78
K032953	EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT	Pulpdent Corporation	2003-12-10	79
K031915	PULPDENT ETCH-RITE ROYALE	Pulpdent Corporation	2003-08-05	46
K031877	EMBRACE WET-BOND RESTORATIVE MATERIAL	Pulpdent Corporation	2003-08-01	45
K030036	TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMEN	Pulpdent Corporation	2003-03-12	68
K022492	PULPDENT SEMI-GEL ETCH	Pulpdent Corporation	2002-10-11	74
K022734	PULPDENT CALCIUM HYDROXIDE PREPARATION	Pulpdent Corporation	2002-10-07	52
K022522	PULPDENT PUTTY DAM	Pulpdent Corporation	2002-09-26	58
K020514	PULPDENT GLAZE II	Pulpdent Corporation	2002-05-16	90
K020481	PULPDENT POST CEMENT	Pulpdent Corporation	2002-04-17	63
K020432	PULPDENT GLAZE	Pulpdent Corporation	2002-04-17	68
K020287	DENTITION INTEGRATING MATERIAL	Pulpdent Corporation	2002-04-12	74

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