Unicep: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Unicep” (first 1993, latest 1993), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 158 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| ELL | Teeth, Porcelain | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| ECM | Band, Preformed, Orthodontic | 1 | 1 |
| EKM | Gutta-Percha | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
Review panels
- Dental (9)
Most recent Unicep 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925163 | MICODOSE CHLORHEXIPREP | ECM | 1993-05-27 | 226 |
| K925162 | MICRODOSE DENTIN CONDITIONER | EBF | 1993-03-16 | 154 |
| K924824 | MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE | EBC | 1993-03-16 | 169 |
| K924823 | MICRODOSE SILANE | ELL | 1993-03-16 | 169 |
| K924821 | MICRODOSE PORCELAIN ETCHANT | ELL | 1993-03-16 | 169 |
| K924827 | MICRODOSE POTASSIUM OXYLATE | LBH | 1993-03-05 | 158 |
| K924826 | MICRODOSE TOTAL ETCHANT | EBF | 1993-03-05 | 158 |
| K924825 | MICRODOSE RC-EZ | EKM | 1993-03-05 | 158 |
| K924822 | MICRODOSE ENAMEL ETCHANT | EBF | 1993-03-05 | 158 |
Recalls
openFDA lists no recalls under a recalling firm named Unicep.
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 Unicep?
FDA lists 9 510(k) clearances under the applicant name “Unicep” (first 1993, latest 1993), across 6 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 Unicep?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unicep is 158 days.
Which FDA product codes appear under Unicep?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 3); ELL (Teeth, Porcelain, 2); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Next steps
- See all 9 Unicep clearances with predicates and recalls
- Run predicate analysis for product code EBF, Unicep'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.