FDA.reportPublic FDA data

PRIME DENTAL MANUFACTURING, INC.

Matched from indexed company URL: PRIME DENTAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14244423002811563PRIME DENTAL MANUFACTURING, INC.1N2026-01-014555 W Addison St CHICAGO IL US 60641

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00817441020005Prime-Dent Visible Light Cure Nano-Hybrid Composite - Visible Light Cure Nano-Hybrid Composite773-283-2914primedental@hotmail.com
00817441022658Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive - A 5th generation, single component, multi-use adhesive and glue.773-283-2914qa@primedentalmfg.com
00817441023136Prime Dent Etchant Liquid - Etchant gel and conditioner.773-283-2914qa@primedentalmfg.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
567061907544956K994224PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIALEBF2000-01-31
567061278331237K112574PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENTEMA2012-01-23
567061070006097K022675PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIALEBF2002-11-07
567061661327627K021524LIGHT CURE DENTAL DAMEIE2002-07-19
567061374833244K013970PRIME-DENT HEMA DESENSITIZEREBF2002-02-19
567061003393932K012794PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANTEBF2001-11-05
567061615257382K012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANTEBC2001-11-01
567061276756013K012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEMDYH2001-10-24
567061693730199K001108PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIALEBF2000-05-30
567061023880775
567061071637352
567061252219596
567061371414856
567061389480010
567061408077497
567061533273784
567061576811537
567061697126692
567061827258121
567062045822537

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF52002-11-07
EMA12012-01-23
EIE12002-07-19
EBC12001-11-01
DYH12001-10-24

NDC#

Prime-Gel

Prime Dental Manufacturing, Inc.

Benzocaine

PMN#

GUDID#