Inter-Med/Vista Dental Products: FDA clearances and approvals
Inter-Med/Vista Dental Products has 6 FDA 510(k) clearances (first 2017, latest 2020), across 4 product codes in 1 review panel. Median 510(k) review time: 136 days. Since 2017 its median was 136 days, against 152 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 148 |
| 2018 | 0 | — |
| 2019 | 1 | 125 |
| 2020 | 4 | 182 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Inter-Med/Vista Dental Products's cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KJJ | Cleanser, Root Canal | 2 | 2 |
| MVL | Cord, Retraction | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| LFC | Device, Caries Detection | 1 | 1 |
Review panels
- Dental (6)
Most recent Inter-Med/Vista Dental Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193357 | V-Mix | KJJ | 2020-10-23 | 324 |
| K193409 | Vista Rinse, Vista Rinse Plus | KJJ | 2020-09-09 | 275 |
| K193447 | Vista Dyes | LFC | 2020-03-11 | 89 |
| K193389 | Vista Clear | MVL | 2020-03-04 | 89 |
| K190220 | Vista FS, Vista FS Liquid | MVL | 2019-06-10 | 125 |
| K170101 | Valiant Curing Light | EBZ | 2017-06-08 | 148 |
Recalls
openFDA lists no recalls under a recalling firm named Inter-Med/Vista Dental Products.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Inter-Med/Vista Dental Products have?
Inter-Med/Vista Dental Products has 6 FDA 510(k) clearances (first 2017, latest 2020), across 4 product codes in 1 review panel.
How long does FDA take to clear Inter-Med/Vista Dental Products's 510(k)s?
The median time from FDA receipt to decision across Inter-Med/Vista Dental Products's cleared 510(k)s is 136 days. Since 2017: 136 days, versus 152 days for all cleared 510(k)s in the same product codes.
What devices does Inter-Med/Vista Dental Products make?
Its most frequent FDA product codes are KJJ (Cleanser, Root Canal, 2); MVL (Cord, Retraction, 2); EBZ (Activator, Ultraviolet, For Polymerization, 1).
Has Inter-Med/Vista Dental Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Inter-Med/Vista Dental Products. Related entities may recall under other names.
Next steps
- See all 6 Inter-Med/Vista Dental Products clearances with predicates and recalls
- Run predicate analysis for product code KJJ, Inter-Med/Vista Dental Products's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.