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

Kulzer, Inc. — Predicate Candidate Screening

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

67 daysmedian FDA review time

161 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K904928	PALAVIT GLC	Kulzer, Inc.	1991-06-06	218
K905058	PALAVIT L	Kulzer, Inc.	1991-06-06	210
K910263	CHARISMA	Kulzer, Inc.	1991-06-03	132
K910719	SILICOATER MD	Kulzer, Inc.	1991-04-29	68
K905131	DURAFILL COLOR VS	Kulzer, Inc.	1991-03-15	120
K905302	DENTHESIVE	Kulzer, Inc.	1991-02-26	90
K904555	DURAFILL FLOW	Kulzer, Inc.	1990-11-13	39
K903317	DENTALON PLUS	Kulzer, Inc.	1990-08-13	19
K902115	PALAPRESS(R) VARIO RESIN	Kulzer, Inc.	1990-07-27	78
K902350	PALATRAY LC RESIN IMPRESSION TRAY MATERIAL	Kulzer, Inc.	1990-07-26	62
K901789	PALADON(R) 65	Kulzer, Inc.	1990-06-22	64
K901697	SILISTOR CERAMIC AND RESIN REPAIR SYSTEM	Kulzer, Inc.	1990-06-15	66
K901681	FORMASIL(R)A POLYVINYL SILOXANE LINE	Kulzer, Inc.	1990-06-15	65
K892453	KULZER GLAS-IONOMER CEMENT	Kulzer, Inc.	1989-12-04	238
K892455	KULZER ADHESIVE CEMENT	Kulzer, Inc.	1989-06-22	73
K892454	KULZER INLAY SYSTEM	Kulzer, Inc.	1989-06-16	67
K892452	PALASEAL(R)	Kulzer, Inc.	1989-06-16	67
K892456	KULZER TRANSLUX EC	Kulzer, Inc.	1989-06-14	65
K875344	HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY	Kulzer, Inc.	1988-03-18	79
K862546	MICROFILL PONTIC	Kulzer, Inc.	1986-10-14	103
K863315	MULTIFIL(R) VS	Kulzer, Inc.	1986-09-22	27
K863314	ESTILUX(R) POSTERIOR C	Kulzer, Inc.	1986-09-22	27
K850965	KULZER DENTIN ADHESIVE	Kulzer, Inc.	1985-04-22	45
K843823	TRANSLUX CL	Kulzer, Inc.	1984-12-04	67
K840176	ESTIC MICROFILL	Kulzer, Inc.	1984-04-13	87
K831215	DENTACOLOR LIGHT CURING CROWN & BRIDGE	Kulzer, Inc.	1983-09-12	151
K831077	DENTALON	Kulzer, Inc.	1983-09-12	161
K813568	ESTILUX POSTERIOR XR	Kulzer, Inc.	1982-01-29	38
K812889	ESTILUX POSTERIOR	Kulzer, Inc.	1981-11-17	33
K811668	KULZER TRANSLUX VISIBLE LIGHT CURING	Kulzer, Inc.	1981-07-28	43
K811669	DURAFILL MICROFILL RESTORATIVE MATERIAL	Kulzer, Inc.	1981-07-01	16

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