Novocol, Inc.
Novocol, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2014, with 2 FDA device recalls on record.
Top product codes for Novocol, Inc.
FDA recalls by Novocol, Inc.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Novocol, Inc.
- K141994 — BULK FILL FLOWABLE COMPOSITE
- K130601 — BIOROOT RCS
- K120237 — BPA-FREE MICROHYBID COMPOSITE
- K120283 — DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
- K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVE
- K110484 — SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
- K092501 — LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
- K072150 — DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL
- K040343 — TEMP F
Data sourced from openFDA. This site is unofficial and independent of the FDA.