Medical Device Manufacturer · US , Washington , DC

Specialites Septodont

21 submissions · 21 cleared · Since 1985
21
Total
21
Cleared
0
Denied

Specialites Septodont — FDA 510(k) Submissions

Specialites Septodont has submitted 21 FDA 510(k) premarket notifications since 1985, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Cement, Dental, Needle, Dental, Liner, Cavity, Calcium Hydroxide, Burnisher, Operative, Container, Sharps . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
K012427 · EAT Tester, Pulp · Dental
Oct 2001 70d
ISODAN
K010415 · KLE Agent, Tooth Bonding, Resin · Dental
Jul 2001 161d
QUICKSET LIQUID AND POWDER
K982773 · EMA Cement, Dental · Dental
Nov 1998 88d
SECURALLOY
K982671 · EJJ Alloy, Amalgam · Dental
Oct 1998 80d
ENDOSOLV E
K980633 · KIF Resin, Root Canal Filling · Dental
May 1998 71d
SEPTOCALCINE ULTRA
K920692 · EJK Liner, Cavity, Calcium... · Dental
Apr 1992 67d
SEPTOPACK TEMPORARY FILLING
K915466 · EBG Crown And Bridge,... · Dental
Feb 1992 60d
CIMPAT S DENTAL CEMENT
K915467 · EMA Cement, Dental · Dental
Feb 1992 60d
SAFETY PLUS DENTAL INJECTION NEEDLE
K913573 · DZM Needle, Dental · Dental
Nov 1991 87d
AUTOPACK NON-EUGENOL PERIODONTAL DRESSING
K913572 · EMA Cement, Dental · Dental
Oct 1991 58d
SEPTOCAL CAVITY LINER
K913574 · EJK Liner, Cavity, Calcium... · Dental
Sep 1991 49d
HEXIDIS ALCOHOL SWAB
K910735 · LKB Pad, Alcohol, Device... · General Hospital
Apr 1991 40d
CYANODONT DENTAL CEMENT
K901082 · EMA Cement, Dental · Dental
Jul 1990 124d
DISPOSINEEDLE SHARPS DISPOSAL UNIT
K897095 · MMK Container, Sharps · General Hospital
Jan 1990 27d
SILCOT COPAL CAVITY VARNISH
K895798 · EMA Cement, Dental · Dental
Dec 1989 84d
CIMPAT S TEMPORARY DENTAL CEMENT
K885007 · EMA Cement, Dental · Dental
Mar 1989 90d
RACESTYPTINE
K884653 · EKJ Burnisher, Operative · Dental
Jan 1989 73d
PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT
K881890 · EMA Cement, Dental · Dental
Jul 1988 71d
IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT
K881661 · EMA Cement, Dental · Dental
Jun 1988 53d
SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE
K851524 · DZM Needle, Dental · Dental
Sep 1985 160d
SEPTOSIL SILICONE FOR PRECISION IMPRESSION
K851388 · ELW Material, Impression · Dental
May 1985 50d
Filters