Angelus Industria DE Produtos Odontologicos S/A: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Angelus Industria DE Produtos Odontologicos S/A” (first 2018, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 281 days. Since 2017 the median was 281 days, against 110 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 2 | 170 |
| 2019 | 2 | 314 |
| 2020 | 0 | — |
| 2021 | 1 | 281 |
| 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 Angelus Industria DE Produtos Odontologicos S/A took a median 281 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | 5 | 5 |
Review panels
- Dental (5)
Most recent Angelus Industria DE Produtos Odontologicos S/A 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201222 | Bio-C Repair Ion+ | KIF | 2021-02-11 | 281 |
| K190537 | BIO-C Sealer Ion+ | KIF | 2019-12-12 | 283 |
| K180199 | BIO-C TEMP | KIF | 2019-01-04 | 345 |
| K180185 | BIO-C REPAIR | KIF | 2018-08-31 | 220 |
| K172701 | BIO-C SEALER | KIF | 2018-01-04 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Angelus Industria DE Produtos Odontologicos S/A.
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.
- Angelus Industria DE Productos Odontologicos (4 510(k)s)
- Angelus Industria DE Productos Odontologicos SA (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Angelus Industria DE Produtos Odontologicos S/A?
FDA lists 5 510(k) clearances under the applicant name “Angelus Industria DE Produtos Odontologicos S/A” (first 2018, latest 2021), across 1 product code 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 Angelus Industria DE Produtos Odontologicos S/A?
The median time from FDA receipt to decision across 510(k)s cleared under the name Angelus Industria DE Produtos Odontologicos S/A is 281 days. Since 2017: 281 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Angelus Industria DE Produtos Odontologicos S/A?
The most frequent FDA product codes under this applicant name are KIF (Resin, Root Canal Filling, 5).
Next steps
- See all 5 Angelus Industria DE Produtos Odontologicos S/A clearances with predicates and recalls
- Run predicate analysis for product code KIF, Angelus Industria DE Produtos Odontologicos S/A'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.