Not currently registered with FDA under this name
Novocol, Inc.
Louisville, CO, United States. Named as applicant on 9 dental 510(k) clearances between 2004 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 92004–2014
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Novocol, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Novocol, Inc. | 9 clearances | 2004–2014 | Below |
| Taiwan | TFDA | Manufacturer | NOVOCOL, INC.Novocol, Inc. | 2 | 2010–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Novocol, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Nov 2014 | K141994 | BULK FILL FLOWABLE COMPOSITE | EBF Resin Tooth Shade Material |
| 17 Oct 2013 | K130601 | BIOROOT RCS | KIF Root Canal Filling Resin |
| 11 Dec 2012 | K120237 | BPA-FREE MICROHYBID COMPOSITE | EBF Resin Tooth Shade Material |
| 31 Jul 2012 | K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | EMA Dental Cement |
| 21 May 2012 | K120619 | ORTHODONTIC FLOWABLE BRACKET ADHESIVE | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 17 May 2011 | K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | EBG Resin Temporary Crown and Bridge |
| 12 Nov 2009 | K092501 | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL | EBF Resin Tooth Shade Material |
| 13 Sep 2007 | K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | EBF Resin Tooth Shade Material |
| 3 Aug 2004 | K040343 | TEMP F | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Septodont (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.