Registered with FDA
Purple Dental Tech
Houston, TX, United States. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Purple Dental Tech currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | Exquisite Dental TechPurple Dental Lab | 2009 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | Exquisite Dental TechPurple Dental Lab | 2009 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Lister | Exquisite Dental TechPurple Dental Lab | 2009 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | Exquisite Dental TechPurple Dental Lab | 2009 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | Exquisite Dental TechPurple Dental Lab | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Purple Dental Tech lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentsply Intl., Inc. (5), Ivoclar Vivadent, AG (2), Argen Precious Metals, Inc. (2), Mountain Medico, Inc. (1), Austenal, Inc. (1), Precious Chemicals U.S.A., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Aug 2007 | K071848 | IPS INLINE POM SYSTEM | Ivoclar Vivadent, AG | EIH Porcelain Powder |
| 14 Oct 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | Ivoclar Vivadent, AG | EIH Porcelain Powder |
| 7 May 2003 | K030632 | PD CASTA-H | Mountain Medico, Inc. | EJH Base Metal Alloy |
| 6 Oct 1999 | K992956 | LUCITONE FRS FLEXIBEL DENTAL RESIN | Dentsply Intl., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 16 Sep 1997 | K972573 | LIQCRYLIC PRO DENTAL RESIN | Dentsply Intl., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Apr 1997 | K970205 | VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY | Austenal, Inc. | EJH Base Metal Alloy |
| 28 Apr 1994 | K932243 | GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO | Precious Chemicals U.S.A., Inc. | EJT Gold-Based Noble Metal Alloy |
| 29 Jan 1991 | K905811 | ARGENCO 52HN | Argen Precious Metals, Inc. | EJT Gold-Based Noble Metal Alloy |
| 30 May 1989 | K891989 | ARGEDENT 52 (DENTAL ALLOY) | Argen Precious Metals, Inc. | EJT Gold-Based Noble Metal Alloy |
| 2 Aug 1984 | K842551 | BASE METAL ALLOY | Dentsply Intl., Inc. | EJH Base Metal Alloy |
| 4 Jan 1980 | K792245 | TEETH, DENTURE, PLASTIC | Dentsply Intl., Inc. | ELM Teeth Plastic Denture |
| 30 Nov 1979 | K792042 | DENTURE BASE RESIN | Dentsply Intl., Inc. | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PURPLE DENTAL TECHFDA reg. 3004905070 | Houston, TX, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10025843). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.