Vivadent (Usa), Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Vivadent (Usa), Inc.” (first 1978, latest 1986), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 27 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| EMA | Cement, Dental | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EAY | Light, Fiber Optic, Dental | 1 | 1 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | 1 | 1 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (17)
Most recent Vivadent (Usa), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863831 | VIVADENT FILPIN | EBL | 1986-10-14 | 14 |
| K823409 | HELIOSIT-ORTHODONTIC | DYH | 1983-01-21 | 67 |
| K813015 | HELIOSEAL | EBC | 1981-12-02 | 36 |
| K802679 | SILANIT | EBG | 1980-12-17 | 50 |
| K802684 | HELIOMAT | EAY | 1980-11-24 | 27 |
| K802683 | HELIOSIT | EBF | 1980-11-24 | 27 |
| K802682 | CONTACT SEAL | EBC | 1980-11-24 | 27 |
| K802681 | HELIOBOND | KLE | 1980-11-24 | 27 |
| K802685 | REOLIT | EJK | 1980-11-12 | 15 |
| K802680 | ISOPAST-DS | EBF | 1980-11-12 | 15 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vivadent (Usa), Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vivadent (Usa), Inc.?
FDA lists 17 510(k) clearances under the applicant name “Vivadent (Usa), Inc.” (first 1978, latest 1986), across 11 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vivadent (Usa), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vivadent (Usa), Inc. is 27 days.
Which FDA product codes appear under Vivadent (Usa), Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 4); EMA (Cement, Dental, 3); EBC (Sealant, Pit And Fissure, And Conditioner, 2).
Next steps
- See all 17 Vivadent (Usa), Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Vivadent (Usa), Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.