510(k) Report

FDA applicant

Oraltronics Dental Implant Technology GmbH

Lubbock, TX1 decision2005–20050 recalls

FDA records 1 decision for Oraltronics Dental Implant Technology GmbH (Lubbock, TX) in 2005: 1 510(k) clearance. All are in product code LYC (Bone Grafting Material, Synthetic). Its devices cite 1 predicate, 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 Oraltronics Dental Implant Technology GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oraltronics Dental Implant Technology GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oraltronics Dental Implant Technology GmbH 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, Synthetic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K050260Bioresorb Macro PoreOraltronics Dental Implant Technology GmbH · 20052cite it

What has FDA decided for it lately?

  • K050260Bioresorb Macro PoreOraltronics Dental Implant Technology GmbH · 2005

The one decision as Oraltronics Dental Implant Technology GmbH →

Other applicant names beginning “Oraltronics”

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

Oraltronics Marketing-Und Vertriebs GmbH 1