Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1424442

FEI Number

3002811563

Entity Name

PRIME DENTAL MANUFACTURING, INC.

City/State/Country

CHICAGO, IL, US

Establishment Address

4555 W Addison St, CHICAGO, IL 60641, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRIME DENTAL MANUFACTURING, INC. (Owner Number: 9039081)

Owner / Operator Contact Address

4555 WEST ADDISON STREET, --, Chicago, IL 60641, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001108

PMA Number

N/A

All Registered Proprietary Names

Prime Blend Ultra Light Cure Soft Dental Dam Dental Dam Prime-Dent Hema Desensitizer Prime-Dent Temporary Cement Prime-Dent Automix Dual Cure Luting Cement Prime-Dent Dual Cure Luting Cement Prime-Dent Non Eugenol Temporary Cement Prime-Dent Visible Light Cure Luting Cement Prime-Dent Glass Ionomer Light Cured Restorative Prime-Dent Glass Ionomer Restorative Prime-Dent Glass Ionomer Cement Prime-Paste APIG Pressure Indicating Gel Prime-Dent Megaset Prime-Dent Visible Light Cure Orthodontic Adhesive Prime-Dent One Step Orthodontic Adhesive Prime-Dent Dual Cure Glass Ionomer Band Cement Prime-Dent Light Cure Glass Ionomer Band Cement Prime-Dent Visible Chemical Cure Pit and Fissure Top Chain - Continues Top Cahin - Long Top Sticks Top Sticks - Minis Top Chain - Minis Prime-Dent White Fluoride Varnish Prime-Dent Visible Light Cure Pit and Fissure Prime-Dent Light Cure Core Build Up Material Prime-Core Prime-Dent Chemical Core Build Up Material Prime-Dent Automix Dual Cure Core Build Up Material Prime-Crown Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive Prime-Dent Chemical Cure Composite Restorative Material Prime-Dent Root Canal Filling Material RC-CREAM Prime-Dent Tray Adhesive Prime-Dent Alginate Flavoring Prime-Dent Porcelain Repair Kit Prime-Dent Parafil Prime-Dent Parafil Separator Prime-Dent Parafil Modifier Prime-Dent Parafil Stains Prime-Dent Silane Bond Enhancer Prime-Dent Parafil Gingiva Prime-Dent Surface Sealant Prime-Dent Parafil LAB Prime-Dent Etchant Gel Prime-Dent Porcelain Etchant Gel Prime-Dent Light Cure One Step Dentin/Enamel Bonding Adhesive Prime-Dent Light Cure Dentin/Enamel Bonding Adhesive Prime-Dent Parafil Modeler Prime-Dent Citric Acid Prime-Dent Self Etch Bonding Agent Prime-Dent Parafil Primer Prime-Dent Visible Light Cure Composite Restorative Material Prime-Dent Etchant Liquid Prime-Dent Visible Light Cure Micro-Hybrid Composite Prime-Dent Visible Light Cure Nano-Hybrid Composite Prime-Dent Visible Light Cure Hybrid Composite Prime-Dent Visible Light Cure Flowable Composite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIE	Dam, Rubber	Dental	Class 1	872.6300	2013-07-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-02-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2013-02-05
EIE	Dam, Rubber	Dental	Class 1	872.6300	2004-12-07
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2025-04-28
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2016-01-11
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2013-02-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-02-05
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2017-08-22
PME	External Cleaning Solution	Dental	Class 2	872.3260	2019-06-12
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2013-02-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-02-05
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2017-08-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2013-02-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2013-02-05
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2017-08-22
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2019-06-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	1999-09-21

Official Correspondent

Pedro Segura

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRIME DENTAL MANUFACTURING, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1424442. Last updated year: 2026. Please use registration number 1424442 when referencing this establishment in official correspondence.