510(k) Report

FDA applicant

Whip-Mix Corp.

Louisville, KY10 decisions2008–20250 recalls

FDA records 10 decisions for Whip-Mix Corp. (Louisville, KY) from 2008 to 2025: 10 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and EIH (Powder, Porcelain). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 185 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Whip Mix Corporation”, “Whip Mix 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 Whip-Mix Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 12009: 12010: 12014: 42016: 12019: 12025: 1
2008high 4 (2014) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Whip-Mix Corp. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NHAAbutment, Implant, Dental, Endosseous3decisions
  • EIHPowder, Porcelain2decisions
  • MQCMouthguard, Prescription2decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision
  • EJRAgent, Polishing, Abrasive, Oral Cavity1decision
  • EBGCrown And Bridge, Temporary, Resin1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 258 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 185 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K082299Vericore Implant AbutmentsWhip-Mix Corp. · 20082cite it
  • K190107VeriSplintWhip Mix Corporation · 20192cite it
  • K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp. · 20091cites it
  • K142670Vericore Zirconia BlanksWhip Mix Corporation · 20141cites it
  • K140877Vericore Zirconia BlanksWhip Mix Corp. · 20141cites it

What has FDA decided for it lately?

  • K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation · 2025
  • K190107VeriSplintWhip Mix Corporation · 2019
  • K152443Vericore Gradient Temporary DiscWhip Mix Corporation · 2016
  • K142670Vericore Zirconia BlanksWhip Mix Corporation · 2014
  • K140877Vericore Zirconia BlanksWhip Mix Corp. · 2014
  • K140146Comfortsoft Soft Denture Liner SystemWhip Mix Corp. · 2014
  • K131760Whip Mix Preppies PlusWhip-Mix Corp. · 2014
  • K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp. · 2010

All 4 as Whip-Mix Corp. →All 4 as Whip Mix Corporation →All 2 as Whip Mix Corp. →