Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kettenbach GmbH & Co. KG · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
167 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fi | Kettenbach GmbH & Co. KG | 2025-03-14 | 43 | 0 |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluor | Kettenbach GmbH & Co. KG | 2023-07-24 | 167 | 0 |
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG | 2019-11-08 | 151 | 0 |
| K191523 | Visalys Restorative Primer | Kettenbach GmbH & Co. KG | 2019-10-09 | 121 | 0 |
| K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019-09-29 | 111 | 0 |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL | Kettenbach GmbH & Co. KG | 2015-03-25 | 147 | 0 |
| K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+ | Kettenbach GmbH & Co. KG | 2012-12-27 | 169 | 0 |
| K113279 | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTI | Kettenbach GmbH & Co. KG | 2011-11-14 | 7 | 0 |
| K092867 | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT | Kettenbach GmbH & Co. KG | 2009-10-01 | 13 | 0 |
| K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | Kettenbach GmbH & Co. KG | 2009-01-09 | 25 | 0 |
| K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRA | Kettenbach GmbH & Co. KG | 2008-09-08 | 4 | 0 |
| K082157 | KETTOSIL AND SILGINAT | Kettenbach GmbH & Co. KG | 2008-08-06 | 6 | 0 |
| K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCA | Kettenbach GmbH & Co. KG | 2008-05-01 | 10 | 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