510(k) Report

FDA applicant

Ceramed Dental, LLC

Lakewood, CO2 decisions1998–19980 recalls

FDA records 2 decisions for Ceramed Dental, LLC (Lakewood, CO) in 1998: 2 510(k) clearances. All are in product code LYC (Bone Grafting Material, Synthetic). 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 Ceramed Dental, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ceramed Dental, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ceramed Dental, LLC 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?

  • LYCBone Grafting Material, Synthetic2decisions

Who builds on its devices?

Later devices cite its devices 5 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.

  • K981214Osteograf/N-700Ceramed Dental, LLC · 19983cite it
  • K981182Osteograf/N-300Ceramed Dental, LLC · 19982cite it

What has FDA decided for it lately?

  • K981182Osteograf/N-300Ceramed Dental, LLC · 1998
  • K981214Osteograf/N-700Ceramed Dental, LLC · 1998

All 2 as Ceramed Dental, LLC →

Other applicant names beginning “Ceramed”

FDA records each applicant name separately; these may or may not be the same firm.

Ceramed Corp. 17