510(k) Report

FDA applicant

Bonafix Surgical and Dental Implants, LLC

118 W Prive Cr., FL3 decisions2012–20170 recalls

FDA records 3 decisions for Bonafix Surgical and Dental Implants, LLC (118 W Prive Cr., FL) from 2012 to 2017: 3 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bonafix Surgical and Dental Implants”.

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 Bonafix Surgical and Dental Implants, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2012: 22017: 1
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Bonafix Surgical and Dental Implants, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bonafix Surgical and Dental Implants…’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?

  • DZEImplant, Endosseous, Root-Form2decisions
  • OATImplant, Endosseous, Orthodontic1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K113650Orthofix ScrewBonafix Surgical and Dental Implants, LLC · 20121cites it

What has FDA decided for it lately?

  • K162853Bonafix TWO - Dental Implant SystemBonafix Surgical and Dental Implants · 2017
  • K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC · 2012
  • K113650Orthofix ScrewBonafix Surgical and Dental Implants, LLC · 2012

All 2 as Bonafix Surgical and Dental Implants, LLC →The one decision as Bonafix Surgical and Dental Implants →