510(k) Report

FDA applicant

Closure Medical Corp.

Raleigh, NC5 decisions1998–20102 recalls

FDA records 5 decisions for Closure Medical Corp. (Raleigh, NC) from 1998 to 2010: 3 510(k) clearances, 1 De Novo grant and 1 original PMA approval. Most are in product codes EMA (Cement, Dental) and KMF (Bandage, Liquid). Its devices cite 4 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Closure Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Closure Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EMACement, Dental1decision
  • KMFBandage, Liquid1decision
  • MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief1decision
  • OMDCutaneous Tissue Adhesive With Mesh1decision
  • MPNTissue Adhesive For The Topical Approximation Of Skin1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K002338Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 20016cite it
  • P960052Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp. · 19986cite it
  • DEN090005Prineo Skin Closure SystemClosure Medical Corp. · 20103cite it
  • K980159Octyldent (2-Octyl Cyanoacrylate), 02A01Closure Medical Corp. · 19982cite it

What has FDA decided for it lately?

  • DEN090005Prineo Skin Closure SystemClosure Medical Corp. · 2010
  • K002338Liquiderm Liquid Adhesive BandageClosure Medical Corp. · 2001
  • K991923Soothe-N-Seal Canker Sore ReliefClosure Medical Corp. · 1999
  • P960052Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Closure Medical Corp. · 19982 recalls
  • K980159Octyldent (2-Octyl Cyanoacrylate), 02A01Closure Medical Corp. · 1998

All 5 as Closure Medical Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K813124Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.Feb 2, 2011
  • K813124High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx…Feb 2, 2011