Novocol, Inc.
Louisville, CO, US
Novocol, Inc. appears in FDA device records in Louisville, CO. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Novocol, Inc. between 2004 and 2014. The busiest year on record is 2012, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141994 | BULK FILL FLOWABLE COMPOSITE | EBF | Substantially Equivalent | |
| K130601 | BIOROOT RCS | KIF | Substantially Equivalent | |
| K120237 | BPA-FREE MICROHYBID COMPOSITE | EBF | Substantially Equivalent | |
| K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | EMA | Substantially Equivalent | |
| K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | DYH | Substantially Equivalent | |
| K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | Substantially Equivalent | |
| K092501 | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL | EBF | Substantially Equivalent | |
| K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | EBF | Substantially Equivalent | |
| K040343 | TEMP F | EMA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2129-2014 | Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert. | Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Class II | Terminated | |
| Z-2128-2014 | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. | Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain