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

Specialites Septodont — Predicate Candidate Screening

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

71 daysmedian FDA review time

124 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K012427	PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT	Specialites Septodont	2001-10-09	70
K010415	ISODAN	Specialites Septodont	2001-07-23	161
K982773	QUICKSET LIQUID AND POWDER	Specialites Septodont	1998-11-03	88
K982671	SECURALLOY	Specialites Septodont	1998-10-19	80
K980633	ENDOSOLV E	Specialites Septodont	1998-05-01	71
K920692	SEPTOCALCINE ULTRA	Specialites Septodont	1992-04-21	67
K915466	SEPTOPACK TEMPORARY FILLING	Specialites Septodont	1992-02-03	60
K915467	CIMPAT S DENTAL CEMENT	Specialites Septodont	1992-02-03	60
K913573	SAFETY PLUS DENTAL INJECTION NEEDLE	Specialites Septodont	1991-11-07	87
K913572	AUTOPACK NON-EUGENOL PERIODONTAL DRESSING	Specialites Septodont	1991-10-09	58
K913574	SEPTOCAL CAVITY LINER	Specialites Septodont	1991-09-30	49
K910735	HEXIDIS ALCOHOL SWAB	Specialites Septodont	1991-04-02	40
K901082	CYANODONT DENTAL CEMENT	Specialites Septodont	1990-07-09	124
K897095	DISPOSINEEDLE SHARPS DISPOSAL UNIT	Specialites Septodont	1990-01-17	27
K895798	SILCOT COPAL CAVITY VARNISH	Specialites Septodont	1989-12-21	84
K885007	CIMPAT S TEMPORARY DENTAL CEMENT	Specialites Septodont	1989-03-01	90
K884653	RACESTYPTINE	Specialites Septodont	1989-01-19	73
K881890	PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT	Specialites Septodont	1988-07-15	71
K881661	IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT	Specialites Septodont	1988-06-07	53
K851524	SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE	Specialites Septodont	1985-09-23	160
K851388	SEPTOSIL SILICONE FOR PRECISION IMPRESSION	Specialites Septodont	1985-05-29	50

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