Novocol, Inc.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 9
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2129-2014 | Class II | Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restor | July 16, 2014 |
| Z-2128-2014 | Class II | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose | July 16, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K141994 | BULK FILL FLOWABLE COMPOSITE | November 14, 2014 |
| K130601 | BIOROOT RCS | October 17, 2013 |
| K120237 | BPA-FREE MICROHYBID COMPOSITE | December 11, 2012 |
| K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | July 31, 2012 |
| K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | May 21, 2012 |
| K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | May 17, 2011 |
| K092501 | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL | November 12, 2009 |
| K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | September 13, 2007 |
| K040343 | TEMP F | August 3, 2004 |