Dentauraum, Inc.: FDA clearances and approvals
Dentauraum, Inc. has 24 FDA 510(k) clearances (first 1991, latest 1995), across 19 product codes in 1 review panel. Median 510(k) review time: 95 days.
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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | 4 | 4 |
| DZC | Wire, Orthodontic | 2 | 2 |
| EJF | Bracket, Metal, Orthodontic | 2 | 2 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 1 | 1 |
| DYO | Band, Material, Orthodontic | 1 | 1 |
| DYT | Maintainer, Space Preformed, Orthodontic | 1 | 1 |
| DZB | Headgear, Extraoral, Orthodontic | 1 | 1 |
| DZD | Tube, Orthodontic | 1 | 1 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | 1 | 1 |
| ECI | Band, Elastic, Orthodontic | 1 | 1 |
Plus 9 more product codes.
Review panels
- Dental (24)
Most recent Dentauraum, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952870 | REMANIUM: CS & G-SOFT | EJH | 1995-07-27 | 35 |
| K952867 | REMANIUM:GM 700, GM 380, GM 800, GFH | EJH | 1995-07-27 | 35 |
| K952866 | REMATITAN TITANIUM | EJH | 1995-07-27 | 35 |
| K952865 | REMANIUM: 200,CS, 380, AND CD | EJH | 1995-07-26 | 34 |
| K952868 | DENTAURUM JACKET CROWN & ROOT POSTS | EBL | 1995-07-19 | 27 |
| K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | KMY | 1995-02-13 | 252 |
| K942666 | ORTHALGENAT IMPRESSION MATERIAL | ELW | 1994-08-10 | 65 |
| K936151 | EXTRAORAL HEADGEAR | DZB | 1994-08-01 | 217 |
| K942668 | O-TRAY IMPRESSION TRAYS | EHY | 1994-07-22 | 46 |
| K942665 | ORTHOCENT: LIQUID AND POWDER | EMA | 1994-07-22 | 46 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dentauraum, 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 Dentauraum, Inc. have?
Dentauraum, Inc. has 24 FDA 510(k) clearances (first 1991, latest 1995), across 19 product codes in 1 review panel.
How long does FDA take to clear Dentauraum, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dentauraum, Inc.'s cleared 510(k)s is 95 days.
What devices does Dentauraum, Inc. make?
Its most frequent FDA product codes are EJH (Alloy, Metal, Base, 4); DZC (Wire, Orthodontic, 2); EJF (Bracket, Metal, Orthodontic, 2).
Has Dentauraum, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dentauraum, Inc. Related entities may recall under other names.
Next steps
- See all 24 Dentauraum, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJH, Dentauraum, 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.