Dentaurum: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Dentaurum” (first 2001, latest 2006), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 4 | 4 |
| OAT | Implant, Endosseous, Orthodontic | 3 | 3 |
| EIH | Powder, Porcelain | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
Review panels
- Dental (10)
Most recent Dentaurum 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062733 | TOMAS PIN SD 6, 8, AND 10 MM | OAT | 2006-11-09 | 57 |
| K062732 | TOMAS PIN 6 MM | OAT | 2006-10-25 | 42 |
| K042965 | TOMAS PIN | OAT | 2005-04-15 | 170 |
| K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | DYH | 2003-11-21 | 266 |
| K032195 | DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT | DYH | 2003-10-07 | 81 |
| K030980 | DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE | DYH | 2003-08-25 | 150 |
| K030977 | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE | DYH | 2003-08-25 | 150 |
| K030641 | CONTEC LIGHT | EBZ | 2003-06-10 | 102 |
| K011428 | TRICERAM | EIH | 2001-06-05 | 27 |
| K011425 | CARMEN | EIH | 2001-06-05 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Dentaurum.
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 Dentaurum?
FDA lists 10 510(k) clearances under the applicant name “Dentaurum” (first 2001, latest 2006), 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 Dentaurum?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentaurum is 92 days.
Which FDA product codes appear under Dentaurum?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 4); OAT (Implant, Endosseous, Orthodontic, 3); EIH (Powder, Porcelain, 2).
Next steps
- See all 10 Dentaurum clearances with predicates and recalls
- Run predicate analysis for product code DYH, Dentaurum'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.