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Blue Sky Bio Plan, Version .38

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090607

by Blue Sky Bio Llc

Identifiers

510(k) Number
K090607 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Blue Sky Bio Plan, Version .38 is dental implant planning software that enables clinicians to import CT or CBCT scans, create virtual implant placement plans, design surgical guides, and export STL files for 3D printing. The software supports image reformatting and treatment planning for dental implant procedures.

The product is provided as a downloadable Windows application and is distributed free of charge. It has received FDA 510(k) clearance (traditional, substantially equivalent) under product code LLZ (K090607). The software is intended for use in dental clinical settings and is supplied as a non‑sterile, single‑use digital tool without physical components.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dental Implant Planning Software | BlueSkyPlan by Blue Sky Bio, Download Planning Software Windows - Blue Sky Bio, Blue Sky Plan | dental treatment planning software | United States, Support for BlueSkyPlan software | United States | Blue Sky Plan

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Blue Sky Bio Llc
FDA Applicant
Blue Sky Bio, LLC

Sources (1)

  • FDA 510(k) K090607 24 fields · synced Sep 24, 2026