Not currently registered with FDA under this name
Vivadent (Usa), Inc.
Tonawanda, NY, United States. Named as applicant on 17 dental 510(k) clearances between 1978 and 1986. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 171978–1986
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1976–2026
510(k) clearances
Clearances on which FDA names Vivadent (Usa), Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Oct 1986 | K863831 | VIVADENT FILPIN | EBL Retentive and Splinting Pin and Accessory Instruments |
| 21 Jan 1983 | K823409 | HELIOSIT-ORTHODONTIC | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 2 Dec 1981 | K813015 | HELIOSEAL | EBC Pit and Fissure Sealant and Conditioner |
| 17 Dec 1980 | K802679 | SILANIT | EBG Resin Temporary Crown and Bridge |
| 24 Nov 1980 | K802684 | HELIOMAT | EAY Dental Fiber Optic Light |
| 24 Nov 1980 | K802683 | HELIOSIT | EBF Resin Tooth Shade Material |
| 24 Nov 1980 | K802682 | CONTACT SEAL | EBC Pit and Fissure Sealant and Conditioner |
| 24 Nov 1980 | K802681 | HELIOBOND | KLE Resin Tooth Bonding Agent |
| 12 Nov 1980 | K802685 | REOLIT | EJK Calcium Hydroxide Cavity Liner |
| 12 Nov 1980 | K802680 | ISOPAST-DS | EBF Resin Tooth Shade Material |
| 12 Aug 1980 | K801227 | SILICAP | EMA Dental Cement |
| 4 Jun 1980 | K801229 | BONDALCAP (CARBOXYLATE) | EMA Dental Cement |
| 4 Jun 1980 | K801228 | BONDALCAP (SILICO-PHOSPHATE) | EMA Dental Cement |
| 5 Jun 1979 | K790874 | AMALCAP-NON-GAMMA-2 | EJJ Amalgam Alloy |
| 10 Apr 1979 | K790439 | CONTACT RESIN | EBF Resin Tooth Shade Material |
| 10 Apr 1979 | K790438 | COLORANT | EBD Resin Filling Material Coating |
| 20 Dec 1978 | K781787 | ISOPLAST | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Ivoclar Vivadent, AG (2).
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.