Medental Intl.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medental Intl.” (first 1997, latest 1999), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| EMA | Cement, Dental | 3 | 3 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
Review panels
- Dental (7)
Most recent Medental Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990314 | MULTI-CURE COMPOSITE CEMENT | EBF | 1999-04-02 | 60 |
| K983018 | ZINC PHOSPHATE CEMENT | EMA | 1998-10-22 | 55 |
| K982779 | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 | EMA | 1998-09-30 | 54 |
| K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | EBF | 1998-09-14 | 84 |
| K980990 | POLYCARBOXYLATE CEMENT | EMA | 1998-07-31 | 136 |
| K973919 | CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) | LBH | 1997-12-16 | 62 |
| K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | EBC | 1997-11-25 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Medental Intl..
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 Medental Intl.?
FDA lists 7 510(k) clearances under the applicant name “Medental Intl.” (first 1997, latest 1999), across 4 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 Medental Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medental Intl. is 62 days.
Which FDA product codes appear under Medental Intl.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 3); EBF (Material, Tooth Shade, Resin, 2); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Next steps
- See all 7 Medental Intl. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Medental Intl.'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.