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Novocol, Inc.

United StatesFDA applicant, unverified

Devices
9
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Novocol, Inc. makes

Novocol, Inc. manufactures dental restorative and adhesive materials, including temporary and permanent composites, resin cements, and orthodontic adhesives. Their portfolio includes light-activated and self-cure composites, bulk-fill flowable resins, and nano-hybrid composite restorative materials designed for dental restorations. Temporary crown and bridge materials, as well as BPA-free microhybrid composites, are also part of their product line.

All listed devices fall under Class II regulatory classification in the U.S. and are recorded in the FDA 510(k) clearance registry. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Novocol, Inc., initiated on 2014-07-16. By recorded status: 2 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2014

    • 16 Jul 2014 Z-2128-2014 Class II Terminated Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Distribution: Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to…
      Full distribution text Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
      Submission number: K042614
    • 16 Jul 2014 Z-2129-2014 Class II Terminated Septodont is recalling Self-Etch bond because the material was incorrectly packaged. Distribution: Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to…
      Full distribution text Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
      Submission number: K042614

Frequently asked questions

How many devices does Novocol, Inc. have in the registry?

The registry currently lists 9 devices for Novocol, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Novocol, Inc.'s devices?

Among its 9 most recently registered devices, Novocol, Inc. has devices listed in FDA 510(k) (9 devices).

What risk classes do Novocol, Inc.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Novocol, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Novocol, Inc.?

FDA recall records list 2 recalls initiated by Novocol, Inc., the most recent initiated on 16 Jul 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Novocol, Inc. in the registry?

The most recently registered devices listed for Novocol, Inc. include TEMP F, DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL, BPA-FREE MICROHYBID COMPOSITE and ORTHODONTIC FLOWABLE BRACKET ADHESIVE.

Generated automatically from registry data and not verified by a human reviewer.