S & C Polymer GmbH: FDA clearances and approvals
S & C Polymer GmbH has 20 FDA 510(k) clearances (first 1995, latest 2009), across 8 product codes in 1 review panel. Median 510(k) review time: 69 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 |
|---|---|---|---|
| EMA | Cement, Dental | 7 | 7 |
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| ELW | Material, Impression | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
Review panels
- Dental (20)
Most recent S & C Polymer GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | EMA | 2009-09-25 | 106 |
| K083062 | ROOT CANAL XR | KIF | 2009-03-12 | 149 |
| K083766 | PHOGLASS CEM | EMA | 2009-03-02 | 74 |
| K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | EMA | 2009-01-15 | 171 |
| K081702 | CARBOXYLATE CEM, PHOSPHATE CEM | EMA | 2008-09-05 | 80 |
| K042614 | S&C-SELF ETCH PR-BOND | KLE | 2004-11-22 | 59 |
| K031420 | S & C -BRACKET ADHESIVES | DYH | 2003-08-20 | 107 |
| K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW | 2001-11-01 | 76 |
| K011277 | HARD RELINER | EBI | 2001-06-26 | 61 |
| K011431 | RESIN CEM | EMA | 2001-06-11 | 33 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named S & C Polymer GmbH.
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 S & C Polymer GmbH have?
S & C Polymer GmbH has 20 FDA 510(k) clearances (first 1995, latest 2009), across 8 product codes in 1 review panel.
How long does FDA take to clear S & C Polymer GmbH's 510(k)s?
The median time from FDA receipt to decision across S & C Polymer GmbH's cleared 510(k)s is 69 days.
What devices does S & C Polymer GmbH make?
Its most frequent FDA product codes are EMA (Cement, Dental, 7); EBF (Material, Tooth Shade, Resin, 4); EBI (Resin, Denture, Relining, Repairing, Rebasing, 2).
Has S & C Polymer GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching S & C Polymer GmbH. Related entities may recall under other names.
Next steps
- See all 20 S & C Polymer GmbH clearances with predicates and recalls
- Run predicate analysis for product code EMA, S & C Polymer GmbH'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.