Manufacturer registered with FDA
Blue Sky Bio, LLC
Libertyville, IL, United States. Lists 11 dental device types with FDA across 1 registered establishment, and holds 20 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 29
- 510(k) clearances
- 202000–2024
- Markets registered in
- 415 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Blue Sky Bio, LLC as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Blue Sky Bio, LLC | 20 clearances | 2000–2024 | Below |
| Taiwan | TFDA | Manufacturer | BLUE SKY BIO, LLCBlue Sky Bio, LLC | 8 | 2008–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BLUE SKY BIO LLC | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Blue Sky Bio, LLC | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Blue Sky Bio, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Blue Sky BioBlue Sky Bio Dental Implant SystemBlue Sky Bio Dental Implant System - Bio / ConusBlue Sky Bio Dental Implant System - Double Hex 3 PlatformBlue Sky Bio Dental Implant System - Internal HexBlue Sky Bio Dental Implant System - Internal Octagon TaperBlue Sky Bio Dental Implant System - Internal TaperBlue Sky Bio Dental Implant System - Octagon Regular and Wide ShortBlue Sky Bio Dental Implant System - One PieceBlue Sky Bio Dental Implant System - Tri-Lobe 1 moreBlue Sky Bio Pterygoid Implants and Abutments | 2008 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Blue Sky BioBlue Sky Bio CAD-CAM AbutmentsBlue Sky Bio Dental Implant System - Bio / ConusBlue Sky Bio Dental Implant System - Double Hex 3 PlatformBlue Sky Bio Dental Implant System - Octagon Regular and Wide ShortBlue Sky Bio Pterygoid Implants and AbutmentsZygomatic Implant System | 2009 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Blue Sky Plan - Ortho ModuleBlue Sky Plan Ortho Module | 2019 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | Blue Sky Plan - IBT Module | 2019 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Guide Fixation Pin, Parallel Pin Starter | 2014 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Blue Sky Bio Impression | 2006 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Blue Sky Bio Dental Implant AccessoriesDental Implant Surgical Tray | 2007 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Blue Sky Bio Plan Software - Crown and Bridge Module | 2021 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Blue Sky Bio TAD | 2022 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | Blue Sky Plan Ortho Module | 2023 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Blue Sky Plan - Denture Module | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Blue Sky Bio, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Apr 2024 | K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | NXC Sequential Aligner |
| 24 Feb 2023 | K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | NXC Sequential Aligner |
| 30 Jun 2022 | K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | DZE Root-Form Endosseous Implant |
| 18 Dec 2020 | K202026 | Blue Sky Bio CAD-CAM Abutments | NHA Endosseous Dental Implant Abutment |
| 17 Dec 2020 | K201919 | Blue Sky Bio TAD | OAT Orthodontic Endosseous Implant |
| 12 Aug 2019 | K190491 | Blue Sky Bio Zygomatic Implant System | NHA Endosseous Dental Implant Abutment |
| 9 Nov 2018 | K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | DYW Orthodontic Plastic Bracket |
| 9 Feb 2018 | K180107 | Blue Sky Bio Aligner | NXC Sequential Aligner |
| 4 Aug 2017 | K163251 | Life Essence Universal Porcelain System | EIH Porcelain Powder |
| 29 Apr 2016 | K153064 | Blue Sky Bio Zygomatic Implant System | DZE Root-Form Endosseous Implant |
| 27 Jan 2012 | K112875 | BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 22 Dec 2011 | K110198 | BLUE SKY BIO TCP | LYC Synthetic Bone Grafting Material |
| 19 Apr 2011 | K102034 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 28 Mar 2008 | K073713 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 29 Mar 2007 | K063874 | DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 5 May 2006 | K060957 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Sep 2005 | K051507 | MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Jun 2002 | K021833 | MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 28 Sep 2001 | K010882 | BLUE SKY BIO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 25 May 2000 | K000633 | SYNTHETIC GLASS BONE GRAFT MATERIAL | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Eminent Spine, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BLUE SKY BIO, LLCFDA reg. 3003402534 | Libertyville, IL, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9040515). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.