Not currently registered with FDA under this name
Ivoclar USA, Inc.
Amherst, NY, United States. Named as applicant on 11 dental 510(k) clearances between 1984 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 111984–2001
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1980–2026
510(k) clearances
Clearances on which FDA names Ivoclar USA, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Nov 2001 | K012877 | HIGH GOLD PALLADIUM FREE CERAMIC SOLDER | EJT Gold-Based Noble Metal Alloy |
| 2 Jul 1998 | K981264 | ARISTON PHC | EBF Resin Tooth Shade Material |
| 11 May 1998 | K980986 | PROCAD | EIH Porcelain Powder |
| 17 Aug 1994 | K941849 | PROVIPONT C&B | EBG Resin Temporary Crown and Bridge |
| 4 Nov 1992 | K923644 | DW243-64 | EJS Alloy Other Noble Metal |
| 25 Feb 1987 | K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN | EBI Rebasing Repairing Relining Denture Resin |
| 10 Feb 1987 | K864710 | ISOSIT N | EBF Resin Tooth Shade Material |
| 10 Feb 1987 | K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 10 Feb 1987 | K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | ELM Teeth Plastic Denture |
| 3 Nov 1986 | K863421 | SR-IVOLEN TRAY MATERIAL | EBH Resin Impression Tray Material |
| 3 Dec 1984 | K844349 | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS | ELM Teeth Plastic Denture |
Some of these clearances are listed with FDA today by another company: Ivoclar Vivadent, AG (2), Institut Straumann AG (1).
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.