510(k) Report

FDA applicant

Kay See Dental Mfg. Co.

Kansas City, MO5 decisions1999–20000 recalls

FDA records 5 decisions for Kay See Dental Mfg. Co. (Kansas City, MO) from 1999 to 2000: 5 510(k) clearances. Most are in product codes EBG (Crown And Bridge, Temporary, Resin) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is 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 Kay See Dental Mfg. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kay See Dental Mfg. Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kay See Dental Mfg. Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kay See Dental Mfg. Co.’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?

  • EBGCrown And Bridge, Temporary, Resin1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision
  • EBCSealant, Pit And Fissure, And Conditioner1decision
  • EIAUnit, Operative Dental1decision
  • EMACement, Dental1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K001309Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material, Model 98250Kay See Dental Mfg. Co. · 20001cites it

What has FDA decided for it lately?

  • K001309Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material, Model 98250Kay See Dental Mfg. Co. · 2000
  • K992609Hydro-Cast Silicone Soft-Liner, Model 68400Kay See Dental Mfg. Co. · 1999
  • K991161Hydro-Cast Acrylic Varnish, Model 78125Kay See Dental Mfg. Co. · 1999
  • K990306Hydro-Cast Dental Etching Gel, Model 60025Kay See Dental Mfg. Co. · 1999
  • K990155Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement, Model 70010Kay See Dental Mfg. Co. · 1999

All 5 as Kay See Dental Mfg. Co. →