Curasan AG: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Curasan AG” (first 2002, latest 2018), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 96 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 | 1 | 610 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 277 |
| 2017 | 0 | — |
| 2018 | 1 | 80 |
| 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, 510(k)s cleared under the name Curasan AG took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 6 | 6 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| LPK | 1 | 0 | |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Orthopedic (6)
- Dental (4)
Most recent Curasan AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181721 | Ceracell Ortho Foam | MQV | 2018-09-17 | 80 |
| K160566 | Cerasorb Ortho Foam | MQV | 2016-12-02 | 277 |
| K111105 | CURASAN OSSEOLIVE DENTAL | LYC | 2012-12-20 | 610 |
| K103709 | CERACELL DENTAL | LYC | 2011-03-10 | 80 |
| K102872 | OSBONE DENTAL | LYC | 2011-01-12 | 104 |
| K100841 | BONEOPTIMIZER | MQV | 2010-08-19 | 147 |
| K063106 | REVOIS IMPLANT SYSTEM | NHA | 2007-06-11 | 243 |
| K040216 | CERASORB M ORTHO | MQV | 2004-03-26 | 56 |
| K031651 | MODIFICATION TO CERASORB ORTHO | MQV | 2003-08-13 | 77 |
| K014156 | CERASORB ORTHO | MQV | 2002-03-18 | 89 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P800035 | PMA | PERI-OSS | 1981-03-24 |
Recalls
openFDA lists no recalls under a recalling firm named Curasan AG.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Curasan Ag, Frankfurt Facility (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Curasan AG?
FDA lists 10 510(k) clearances under the applicant name “Curasan AG” (first 2002, latest 2018), plus 1 PMA decision, across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Curasan AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Curasan AG is 96 days.
Which FDA product codes appear under Curasan AG?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 6); LYC (Bone Grafting Material, Synthetic, 3); LPK (device, 1).
Next steps
- See all 10 Curasan AG clearances with predicates and recalls
- Run predicate analysis for product code MQV, Curasan AG'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.