Data / Medical devices / United States / Pan-Am Dental, Inc.

Pan-Am Dental, Inc.: FDA-registered device maker in Sandy, UT, United States, 8 510(k) clearances

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

Pan-Am Dental, Inc. is registered with the FDA (registration 3040605150) in Sandy, UT, United States. It lists 7 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 4, 2003. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3040605150
Address: 9075 S 700 W, Sandy, UT, United States, 84070
Owner or operator: PAN-AM DENTAL, INC. (9066791)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 10, 2007
Registered through: 2026
Brand names listed: ALLOY, METAL, BASE, ALLOY, OTHER NOBLE METAL, Alloy, gold-based noble metal, POWDER, PORCELAIN, RESIN, DENTURE, RELINING, REPAIRING, REBASING, Restoration Noble Metal, Restoration Resin, Restoration, resin, crown and bridge

Devices it lists

Device	Product code	Class	Role	Source
Alloy, Gold-Based Noble Metal	EJT	2	Repackager or relabeler	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Repackager or relabeler	accessdata.fda.gov
Alloy, Other Noble Metal	EJS	2	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Restoration, Noble Metal	NSJ	N	Repackager or relabeler	accessdata.fda.gov
Restoration, Resin, Crown And Bridge	NSN	N	Repackager or relabeler	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
September 4, 2003	K032136	WIROBOND C	EJH	Substantially Equivalent	Bego U.S.A.	accessdata.fda.gov
March 6, 2001	K010381	D.SIGN 30	EJH	Substantially Equivalent	Ivoclar North America, Inc.	accessdata.fda.gov
April 28, 1994	K932243	GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO	EJT	Substantially Equivalent	Precious Chemicals U.S.A., Inc.	accessdata.fda.gov
October 25, 1991	K913372	IPS EMPRESS	EIH	Substantially Equivalent	Ivoclar North America, Inc.	accessdata.fda.gov
February 26, 1991	K905329	WILL-CERAM W	EJT	Substantially Equivalent	Ivoclar North America, Inc.	accessdata.fda.gov
December 24, 1990	K905324	WILL-CERAM W-1	EJT	Substantially Equivalent	Ivoclar North America, Inc.	accessdata.fda.gov
April 16, 1990	K896130	SR-IVOCAP	EBI	Substantially Equivalent	Ivoclar North America, Inc.	accessdata.fda.gov
October 22, 1982	K822950	RX UNIVERSAL	EJS	Substantially Equivalent	Jeneric Ind.	accessdata.fda.gov

Compare with other makers

Updated September 4, 2003. 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.