Data / Medical devices / United States / Prime Dental Manufacturing, Inc.

Prime Dental Manufacturing, Inc.: FDA-registered device maker in Chicago, IL, United States, 9 510(k) clearances

Name: Prime Dental Manufacturing, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Prime Dental Manufacturing, Inc. is registered with the FDA (registration 1424442) in Chicago, IL, United States. It lists 17 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 23, 2012. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Prime Dental Manufacturing, Inc.

FDA registration number: 1424442
FEI number: 3002811563
Address: 4555 W Addison St, Chicago, IL, United States, 60641
Owner or operator: PRIME DENTAL MANUFACTURING, INC. (9039081)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export
First device listed: September 21, 1999
Registered through: 2026
Brand names listed: APIG Pressure Indicating Gel, Dental Dam, Light Cure Soft Dental Dam, Prime Blend Ultra, Prime Dent Zinc Oxide Eugenol Cement, Prime Dent Zinc Oxide Eugenol Reinforced Cement, Prime Dent Zinc Phosphate Cement, Prime Gel and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Manufacturer	accessdata.fda.gov
Applicator, Resin	KXR	1	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Manufacturer	accessdata.fda.gov
Crown, Preformed	ELZ	1	Manufacturer	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer	accessdata.fda.gov
External Cleaning Solution	PME	2	Manufacturer	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Manufacturer	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Manufacturer	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Intraoral	EAP	2	Manufacturer for export	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 23, 2012	K112574	PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT	EMA	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
November 7, 2002	K022675	PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
July 19, 2002	K021524	LIGHT CURE DENTAL DAM	EIE	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
February 19, 2002	K013970	PRIME-DENT HEMA DESENSITIZER	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
November 5, 2001	K012794	PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
November 1, 2001	K012761	PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT	EBC	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
October 24, 2001	K012673	PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM	DYH	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
May 30, 2000	K001108	PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov
January 31, 2000	K994224	PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL	EBF	Substantially Equivalent	Prime Dental Manufacturing, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 23, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.