Medical Device Manufacturer · US , Watertown , MA

Pulpdent Corp.

78 submissions · 78 cleared · Since 1990
78
Total
78
Cleared
0
Denied

Pulpdent Corp. — FDA 510(k) Submissions

Pulpdent Corp. has submitted 78 FDA 510(k) premarket notifications since 1990, of which 78 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Cement, Dental, Varnish, Cavity, Adhesive, Bracket And Tooth Conditioner, Resin, Agent, Tooth Bonding, Resin . Use the specialty filter in the sidebar to narrow results.

78 devices
1–25 of 78
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · DYH Adhesive, Bracket And... · Dental
Mar 2002 87d
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K014138 · DYH Adhesive, Bracket And... · Dental
Mar 2002 87d
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · DYH Adhesive, Bracket And... · Dental
Feb 2002 48d
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · DYH Adhesive, Bracket And... · Dental
Feb 2002 79d
PULPDENT CAVITY PREPARATION IV
K013411 · LBH Varnish, Cavity · Dental
Dec 2001 58d
PULPDENT CAVITY PREPARATION III
K994180 · LBH Varnish, Cavity · Dental
Mar 2000 83d
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
K994181 · LBH Varnish, Cavity · Dental
Feb 2000 81d
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
K994182 · LBH Varnish, Cavity · Dental
Feb 2000 75d
PULPDENT UNO-DUO
K993683 · KLE Agent, Tooth Bonding, Resin · Dental
Dec 1999 42d
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202 · LBH Varnish, Cavity · Dental
Mar 1998 129d
PULPDENT CAVITY VARNISH
K974398 · LBH Varnish, Cavity · Dental
Feb 1998 89d
PULPDENT DENTASTIC UNO
K974014 · EMA Cement, Dental · Dental
Dec 1997 56d
PULPDENT OX-OUT
K972445 · EMA Cement, Dental · Dental
Oct 1997 94d
FLOW-RITE
K971594 · EBF Material, Tooth Shade, Resin · Dental
Sep 1997 134d
PULPDENT SNOOP
K964430 · LFC Device, Caries Detection · Dental
Jan 1997 73d
PULPDENT SEAL-RITE UDMA
K963921 · EBC Sealant, Pit And Fissure,... · Dental
Nov 1996 43d
PULPDENT DESENSITIZER
K963652 · EBF Material, Tooth Shade, Resin · Dental
Oct 1996 29d
PULPDENT ENDODONTIC POST CEMENT KIT
K962747 · EMA Cement, Dental · Dental
Sep 1996 77d
PULPDENT RESILUTE II
K962383 · EMA Cement, Dental · Dental
Sep 1996 75d
PULPDENT SODIUM HYPOCHLORITE SOLUTION
K962743 · KJJ Cleanser, Root Canal · Dental
Aug 1996 22d
PULPDENT ENDOPREP II
K961089 · EKL Point, Silver, Endodontic · Dental
Apr 1996 35d
PULPDENT RESILUTE
K955017 · EMA Cement, Dental · Dental
Dec 1995 29d
PULPDENT TOUCHDOWN
K953217 · DYH Adhesive, Bracket And... · Dental
Aug 1995 46d
PULPDENT DENTASTIC II
K953272 · EMA Cement, Dental · Dental
Aug 1995 43d
DENTASTIC ONE-STEP
K953301 · EMA Cement, Dental · Dental
Aug 1995 42d

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