Novocol, Inc.: FDA clearances and approvals
Novocol, Inc. has 9 FDA 510(k) clearances (first 2004, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time: 115 days. openFDA lists 2 product recalls by a recalling firm named Novocol, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 182 |
| 2013 | 1 | 224 |
| 2014 | 1 | 115 |
| 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 | 4 | 4 |
| EMA | Cement, Dental | 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 (9)
Most recent Novocol, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141994 | BULK FILL FLOWABLE COMPOSITE | EBF | 2014-11-14 | 115 |
| K130601 | BIOROOT RCS | KIF | 2013-10-17 | 224 |
| K120237 | BPA-FREE MICROHYBID COMPOSITE | EBF | 2012-12-11 | 320 |
| K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | EMA | 2012-07-31 | 182 |
| K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | DYH | 2012-05-21 | 82 |
| K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | 2011-05-17 | 88 |
| K092501 | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL | EBF | 2009-11-12 | 90 |
| K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | EBF | 2007-09-13 | 41 |
| K040343 | TEMP F | EMA | 2004-08-03 | 173 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-07-16.
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 Novocol, Inc. have?
Novocol, Inc. has 9 FDA 510(k) clearances (first 2004, latest 2014), across 5 product codes in 1 review panel.
How long does FDA take to clear Novocol, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Novocol, Inc.'s cleared 510(k)s is 115 days.
What devices does Novocol, Inc. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 4); EMA (Cement, Dental, 2); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1).
Has Novocol, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Novocol, Inc; the most recent began 2014-07-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Novocol, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Novocol, Inc.'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.