International Medical Devices Database

Manufacturer Address
Novocol, Inc., 416 S Taylor Ave, Louisville CO 80027-3028
Manufacturer Parent Company (2017)
Novocol Inc.
Source
USFDA
2 Events
- Recall of Device Recall Septodont aka Novocol
- Recall of Device Recall Septodont aka Novocol

2 devices in the database

Device Recall Septodont aka Novocol

Model / Serial
Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
Product Description
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.

Device Recall Septodont aka Novocol

Model / Serial
Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
Product Description
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.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Novocol, Inc.

2 devices in the database

Device Recall Septodont aka Novocol

Device Recall Septodont aka Novocol