Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novocol, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
320 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141994 | BULK FILL FLOWABLE COMPOSITE | Novocol, Inc. | 2014-11-14 | 115 | 0 |
| K130601 | BIOROOT RCS | Novocol, Inc. | 2013-10-17 | 224 | 0 |
| K120237 | BPA-FREE MICROHYBID COMPOSITE | Novocol, Inc. | 2012-12-11 | 320 | 0 |
| K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | Novocol, Inc. | 2012-07-31 | 182 | 0 |
| K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | Novocol, Inc. | 2012-05-21 | 82 | 0 |
| K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | Novocol, Inc. | 2011-05-17 | 88 | 0 |
| K092501 | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE M | Novocol, Inc. | 2009-11-12 | 90 | 0 |
| K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIA | Novocol, Inc. | 2007-09-13 | 41 | 0 |
| K040343 | TEMP F | Novocol, Inc. | 2004-08-03 | 173 | 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