Not currently registered with FDA under this name
Wieland Edelmetalle GmbH & Co.
Pforzheim, Germany. Named as applicant on 14 dental 510(k) clearances between 2000 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 142000–2002
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Wieland Edelmetalle GmbH & Co. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Apr 2002 | K020347 | AGC SPEZIALLEGIERUNG | EJT Gold-Based Noble Metal Alloy |
| 31 Dec 2001 | K012839 | AUROPAL, ORDER-NO.: 2101 | EJT Gold-Based Noble Metal Alloy |
| 20 Nov 2001 | K012841 | DUO PAL 6, ORDER-NO.: 2154 | EJS Alloy Other Noble Metal |
| 2 Nov 2001 | K012843 | PORTADUR P 2, MODEL #2031 | EJT Gold-Based Noble Metal Alloy |
| 1 Nov 2001 | K012835 | PORTA MAXIMUM, MODEL# 2066 | EJT Gold-Based Noble Metal Alloy |
| 1 Nov 2001 | K012834 | PORTA GEO TI MODEL #2004 | EJT Gold-Based Noble Metal Alloy |
| 1 Nov 2001 | K012831 | BIO PORTADUR, ORDER-NO.:2017 | EJT Gold-Based Noble Metal Alloy |
| 1 Nov 2001 | K012828 | PORTA SMK 82, MODEL 2032 | EJS Alloy Other Noble Metal |
| 1 Nov 2001 | K012827 | PORTA AURIUM, MODEL 2067 | EJT Gold-Based Noble Metal Alloy |
| 1 Nov 2001 | K012826 | BIOPORTA G, MODEL 2052 | EJT Gold-Based Noble Metal Alloy |
| 23 Oct 2001 | K012840 | EURO 45, ORDER-NO.: 2064 | EJS Alloy Other Noble Metal |
| 23 Oct 2001 | K012838 | ERO50, ORDER-NO.: 2070 | EJT Gold-Based Noble Metal Alloy |
| 16 Aug 2001 | K012156 | IMAGINE H.E. | EIH Porcelain Powder |
| 23 May 2000 | K001041 | AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD | EJT Gold-Based Noble Metal Alloy |
Sources
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 of the most recent filing, which can be a US agent.