Medical Device Manufacturer · US , Chicago , IL

Prime Dental Manufacturing, Inc.

9 submissions · 9 cleared · Since 2000
9
Total
9
Cleared
0
Denied

Prime Dental Manufacturing, Inc. — FDA 510(k) Submissions

Prime Dental Manufacturing, Inc. has submitted 9 FDA 510(k) premarket notifications since 2000, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Adhesive, Bracket And Tooth Conditioner, Resin, Sealant, Pit And Fissure, And Conditioner, Dam, Rubber, Cement, Dental . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
K112574 · EMA Cement, Dental · Dental
Jan 2012 139d
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
K022675 · EBF Material, Tooth Shade, Resin · Dental
Nov 2002 87d
LIGHT CURE DENTAL DAM
K021524 · EIE Dam, Rubber · Dental
Jul 2002 70d
PRIME-DENT HEMA DESENSITIZER
K013970 · EBF Material, Tooth Shade, Resin · Dental
Feb 2002 78d
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
K012794 · EBF Material, Tooth Shade, Resin · Dental
Nov 2001 76d
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT
K012761 · EBC Sealant, Pit And Fissure,... · Dental
Nov 2001 76d
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
K012673 · DYH Adhesive, Bracket And... · Dental
Oct 2001 71d
PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
K001108 · EBF Material, Tooth Shade, Resin · Dental
May 2000 55d
PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
K994224 · EBF Material, Tooth Shade, Resin · Dental
Jan 2000 47d
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