Dmg USA, Inc.: FDA clearances and approvals
Dmg USA, Inc. has 28 FDA 510(k) clearances (first 2000, latest 2018), across 11 product codes in 1 review panel. Median 510(k) review time: 78 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 357 |
| 2015 | 0 | — |
| 2016 | 1 | 226 |
| 2017 | 0 | — |
| 2018 | 1 | 231 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dmg USA, Inc.'s cleared 510(k)s took a median 231 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 7 | 7 |
| EBG | Crown And Bridge, Temporary, Resin | 5 | 5 |
| EMA | Cement, Dental | 4 | 4 |
| ELW | Material, Impression | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| ELY | Mercury | 1 | 1 |
| EMB | Zinc Oxide Eugenol | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (28)
Most recent Dmg USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171772 | Ecosite Bulk Fill | EBF | 2018-01-31 | 231 |
| K160443 | TempoCem Clear | EMA | 2016-09-30 | 226 |
| K130580 | RETRACTION PASTE | MVL | 2014-02-25 | 357 |
| K110759 | TEMPOCEM | EMB | 2011-06-10 | 84 |
| K102603 | SA FLOWABLE ADHESIVE | EBF | 2010-11-17 | 68 |
| K101710 | LUXATEMP ULTRA /STAR | EBG | 2010-09-28 | 103 |
| K100062 | INFILTRATION KIT | EBC | 2010-03-26 | 74 |
| K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | EMA | 2010-02-12 | 112 |
| K093587 | DENTAL MERCURY | ELY | 2010-01-21 | 63 |
| K081493 | INFILTRATION KIT | EBC | 2008-09-18 | 113 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dmg USA, Inc..
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 Dmg USA, Inc. have?
Dmg USA, Inc. has 28 FDA 510(k) clearances (first 2000, latest 2018), across 11 product codes in 1 review panel.
How long does FDA take to clear Dmg USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dmg USA, Inc.'s cleared 510(k)s is 78 days.
What devices does Dmg USA, Inc. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 7); EBG (Crown And Bridge, Temporary, Resin, 5); EMA (Cement, Dental, 4).
Has Dmg USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dmg USA, Inc. Related entities may recall under other names.
Next steps
- See all 28 Dmg USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Dmg USA, Inc.'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.