510(k) Report

FDA applicant

Salvin Dental Specialties

Charlotte, NC4 decisions2008–20170 recalls

FDA records 4 decisions for Salvin Dental Specialties (Charlotte, NC) from 2008 to 2017: 4 510(k) clearances. Most are in product codes DZL (Screw, Fixation, Intraosseous) and NPK (Barrier, Synthetic, Intraoral). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Salvin Dental Specialties, Inc.”.

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 Salvin Dental Specialties’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 12010: 12016: 12017: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Salvin Dental Specialties by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Salvin Dental Specialties’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DZLScrew, Fixation, Intraosseous3decisions
  • NPKBarrier, Synthetic, Intraoral1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 20082cite it
  • K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties · 20161cites it
  • K100182Salvin Dental Specialties Fixation ScrewSalvin Dental Specialties, Inc. · 20101cites it

What has FDA decided for it lately?

  • K161857Salvin Tenting Screw SystemSalvin Dental Specialties · 2017
  • K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties · 2016
  • K100182Salvin Dental Specialties Fixation ScrewSalvin Dental Specialties, Inc. · 2010
  • K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008

All 2 as Salvin Dental Specialties →All 2 as Salvin Dental Specialties, Inc. →