510(k) Report

FDA applicant

Cdb Corporation

Leland, NC9 decisions1992–20222 recalls

FDA records 9 decisions for Cdb Corporation (Leland, NC) from 1992 to 2022: 9 510(k) clearances. Most are in product codes NJM (Bracket, Ceramic, Orthodontic) and NXC (Aligner, Sequential). Since 2016 its 510(k)s took a median of 165 days from receipt to decision, against 176 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Cdb Corp.”.

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 Cdb Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12009: 12016: 12019: 12021: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cdb Corporation 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?

  • NJMBracket, Ceramic, Orthodontic3decisions
  • NXCAligner, Sequential2decisions
  • EJFBracket, Metal, Orthodontic2decisions
  • DYWBracket, Plastic, Orthodontic1decision
  • PNNOrthodontic Software1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 165 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 176 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K973776ReflectionsCdb Corp. · 19973cite it
  • K080906CDB ClipCdb Corporation · 20082cite it
  • K922499Reflections - Ceramic Dental BracketCdb Corp. · 19922cite it
  • K191823Clear-AlignersCdb Corporation · 20191cites it

What has FDA decided for it lately?

  • K212173HDH Treatment Planning SystemCdb Corporation · 2022
  • K210613HIT Clear AlignerCdb Corporation · 2021
  • K191823Clear-AlignersCdb Corporation · 2019
  • K160957CDB Self Ligating Bracket 8FCdb Corporation · 2016
  • K091702CDB Flip-Side-Clip BracketCdb Corporation · 2009
  • K080906CDB ClipCdb Corporation · 20081 recall
  • K973776ReflectionsCdb Corp. · 1997
  • K934881ReflectionsCdb Corp. · 1994

All 6 as Cdb Corporation →All 3 as Cdb Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K922499Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic…Feb 8, 2013Class III
  • K080906ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG…Jun 3, 2011