Data / Medical devices / United States / Purple Dental Tech

Purple Dental Tech: FDA-registered device maker in Houston, TX, United States, 12 510(k) clearances

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

Purple Dental Tech is registered with the FDA (registration 3004905070) in Houston, TX, United States. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 30, 2007. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004905070
Address: 1438 Campbell Rd Ste 105, Houston, TX, United States, 77055
Owner or operator: Purple Dental Tech (10025843)
Roles: Repackager or relabeler
First device listed: January 20, 2009
Registered through: 2026
Brand names listed: Exquisite Dental Tech, Purple Dental Lab

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
Denture, Plastic, Teeth	ELM	2	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	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
August 30, 2007	K071848	IPS INLINE POM SYSTEM	EIH	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
October 14, 2005	K051705	IPS E.MAX CAD/IPS E.MAX ZIRCAD	EIH	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
May 7, 2003	K030632	PD CASTA-H	EJH	Substantially Equivalent	Mountain Medico, Inc.	accessdata.fda.gov
October 6, 1999	K992956	LUCITONE FRS FLEXIBEL DENTAL RESIN	EBI	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
September 16, 1997	K972573	LIQCRYLIC PRO DENTAL RESIN	EBI	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
April 21, 1997	K970205	VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY	EJH	Substantially Equivalent	Austenal, 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
January 29, 1991	K905811	ARGENCO 52HN	EJT	Substantially Equivalent	Argen Precious Metals, Inc.	accessdata.fda.gov
May 30, 1989	K891989	ARGEDENT 52 (DENTAL ALLOY)	EJT	Substantially Equivalent	Argen Precious Metals, Inc.	accessdata.fda.gov
August 2, 1984	K842551	BASE METAL ALLOY	EJH	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
January 4, 1980	K792245	TEETH, DENTURE, PLASTIC	ELM	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
November 30, 1979	K792042	DENTURE BASE RESIN	EBI	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov

Compare with other makers

Updated August 30, 2007. 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.