Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SeptodontLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Novocol Pharmaceutical of Canada with 11 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Nov 14, 2014: BULK FILL FLOWABLE COMPOSITE.
| Nov 14, 2014 | BULK FILL FLOWABLE COMPOSITEK141994 · EBF | 510(k) clearances |
| Jul 16, 2014 | Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restoClass II · Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Device recalls |
| Jul 16, 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 produClass II · Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Device recalls |
| Oct 17, 2013 | BIOROOT RCSK130601 · KIF | 510(k) clearances |
| Dec 11, 2012 | BPA-FREE MICROHYBID COMPOSITEK120237 · EBF | 510(k) clearances |
| Jul 31, 2012 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENTK120283 · EMA | 510(k) clearances |
| May 21, 2012 | ORTHODONTIC FLOWABLE BRACKET ADHESIVEK120619 · DYH | 510(k) clearances |
| May 17, 2011 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIALK110484 · EBG | 510(k) clearances |
| Mar 31, 2011 | BPA-FREE PIT AND FISSURE SEALANTK110058 · EBC | 510(k) clearances |
| Oct 29, 2010 | GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER COREK101540 · EBF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
