Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S & C Polymer GmbH — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
171 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | S & C Polymer GmbH | 2009-09-25 | 106 | 0 |
| K083062 | ROOT CANAL XR | S & C Polymer GmbH | 2009-03-12 | 149 | 0 |
| K083766 | PHOGLASS CEM | S & C Polymer GmbH | 2009-03-02 | 74 | 0 |
| K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | S & C Polymer GmbH | 2009-01-15 | 171 | 0 |
| K081702 | CARBOXYLATE CEM, PHOSPHATE CEM | S & C Polymer GmbH | 2008-09-05 | 80 | 0 |
| K042614 | S&C-SELF ETCH PR-BOND | S & C Polymer GmbH | 2004-11-22 | 59 | 2 |
| K031420 | S & C -BRACKET ADHESIVES | S & C Polymer GmbH | 2003-08-20 | 107 | 0 |
| K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH | 2001-11-01 | 76 | 0 |
| K011277 | HARD RELINER | S & C Polymer GmbH | 2001-06-26 | 61 | 0 |
| K011431 | RESIN CEM | S & C Polymer GmbH | 2001-06-11 | 33 | 0 |
| K011064 | CLASSIC CEM | S & C Polymer GmbH | 2001-05-17 | 41 | 0 |
| K010012 | LC PROVIFILL | S & C Polymer GmbH | 2001-02-14 | 43 | 0 |
| K002502 | CERAM-PRIME | S & C Polymer GmbH | 2000-11-08 | 86 | 0 |
| K991442 | LC MICROFILL | S & C Polymer GmbH | 1999-06-03 | 38 | 0 |
| K990108 | LC FLOWFILL | S & C Polymer GmbH | 1999-03-09 | 55 | 0 |
| K984483 | A-SOFT RELINER | S & C Polymer GmbH | 1999-02-18 | 64 | 0 |
| K984097 | DC-CORE | S & C Polymer GmbH | 1999-02-09 | 84 | 0 |
| K984484 | LC MICROHYBRID | S & C Polymer GmbH | 1999-01-20 | 35 | 0 |
| K973201 | PROVI CEMENT | S & C Polymer GmbH | 1998-06-05 | 283 | 0 |
| K951075 | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL | S & C Polymer GmbH | 1995-03-31 | 22 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda