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Sign in to claim this brandBLUE SKY BIO LLC
United States·US-MF-000014016
Last updated May 24, 2026
What BLUE SKY BIO LLC makes
Blue Sky Bio LLC manufactures dental implant components, including permanent preformed suprastructures, two-piece screw endosteal implants, and reusable fixture/appliance drill bits. Their portfolio also includes dental implant analogs, ceramic fabrication materials for appliances, suprastructure kits, guided surgery reference pins, and torque wrench adaptors for surgical procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Blue Sky Bio LLC manufacture?
Blue Sky Bio LLC specializes in dental implant-related devices. Their portfolio includes permanent preformed dental implant suprastructures, two-piece screw endosteal dental implants, reusable fixture/appliance drill bits, dental implant analogs, ceramic materials for dental appliance fabrication, suprastructure kits, guided surgery reference pins, and surgical torque wrench adaptors. These products are designed to support dental restoration procedures and surgical precision.
Where is Blue Sky Bio LLC based?
Blue Sky Bio LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support related to its dental implant devices.
Which regulatory registries list Blue Sky Bio LLC’s devices?
Blue Sky Bio LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, ensuring they can verify the identity and regulatory status of the devices in use.
How are Blue Sky Bio LLC’s devices classified under FDA regulations?
Blue Sky Bio LLC’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, intended use, and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 800, Liberty Drive, Libertyville, United States
- Website
- accumedix.com
- —
- —
- [email protected]
- Phone
- 8476822688
- PRRC Contact
- Michele Kupcso
- EUDAMED SRN
- US-MF-000014016
- FDA FEI Number
- —
- DUNS Number
- 618960848
Catalogue (1705)
Page 27 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Drill Guided Sinus Lift 3.6 x 8mm | DRILG-SD3608 | EUDAMEDFDA UDI | Class IIa | Active |
| BIO | Max Implant Driver RP Ratchet Short | DTJHRS | EUDAMEDFDA UDI | Class I | Active |
| Drill N 2.2mm Short | DRILLN22S | EUDAMEDFDA UDI | Class IIa | Active |
| BIO | One Stage Hand Piece Implant Driver Long | DML | EUDAMEDFDA UDI | Class I | Active |
| Drill with Stop 3.6 x 13mm | DRILNSTP3613 | EUDAMEDFDA UDI | Class IIa | Active |
| Bio | Guide-Tube 2.9 OD x 1.9 ID x 4mm L | TUBE29-19-4L | EUDAMEDFDA UDI | Class I | Active |
| BIO | Conus Implant Driver Handpiece 3.5/4.0 Short | DMDH35S | EUDAMEDFDA UDI | Class I | Active |
| BIO | Max Implant Driver Handpiece NP Short | DMJHS | EUDAMEDFDA UDI | Class I | Active |
| BIO | One Stage Hand Piece Implant Driver Short | DMS | EUDAMEDFDA UDI | Class I | Active |
| Drill with Stop-Q 4.3 x 12mm | DRILTSTP4312 | EUDAMEDFDA UDI | Class IIa | Active |
| Guided Drill 3.0 x 13mm | DRILG3013 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill Profile D 4.0mm | DRILLPDH40 | EUDAMEDFDA UDI | Class IIa | Active |
| BIO | Guide-Tube for Cer. M 4.73mm | TUBE53-473 | EUDAMEDFDA UDI | Class I | Active |
| Drill with Stop-Q 2.2 x 8mm | DRILTSTP2208 | EUDAMEDFDA UDI | Class IIa | Active |
| XT Driver Short | DTZJNS | EUDAMEDFDA UDI | Class I | Active |
| Guided Drill 4.6 x 16mm | DRILG4616 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill N Implant 6.0 Short | DRILLN60S | EUDAMEDFDA UDI | Class IIa | Active |
| Drill with Stop 4.4 x 8mm | DRILNSTP4408 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill Profiler 3.2mm ID x 5.5mm OD | DRILLPR55 | EUDAMEDFDA UDI | Class IIa | Active |
| Analog BIO | Conus 12 / 3.0 | BDH30 | EUDAMEDFDA UDI | Class I | Active |
| Drill N Implant 5.7 Long | DRILLH53L | EUDAMEDFDA UDI | Class IIa | Active |
| GUIDED DRILL-Q, 2.8 x 8mm | DRILTG2808 | EUDAMEDFDA UDI | Class IIa | Active |
| BIO | Guide-Tube for Cer. S 3.79mm | TUBE44-379 | EUDAMEDFDA UDI | Class I | Active |
| Drill with Stop-Q 4.3 x 8mm | DRILTSTP4308 | EUDAMEDFDA UDI | Class IIa | Active |
| BIO | Cut Guide Tube 4.0 OD x 3.5 ID x 5mm L | TUBE4-35-5L | EUDAMEDFDA UDI | Class I | Active |
| Drill with Stop 4.6 x 16 mm | DRILNSTP4616 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill T 2.8mm Short | DRILLT28S | EUDAMEDFDA UDI | Class IIa | Active |
| Drill T Starter Short | DRILLTSS | EUDAMEDFDA UDI | Class IIa | Active |
| UNI Driver Long | SDUGL | EUDAMEDFDA UDI | Class I | Active |
| Analog Narrow 7mm | BAN7000 | EUDAMEDFDA UDI | Class I | Active |
| Drill N Implant 4.1 Long | DRILL3630L | EUDAMEDFDA UDI | Class IIa | Active |
| Guided Drill 3.9 x 8mm | DRILG3908 | EUDAMEDFDA UDI | Class IIa | Active |
| Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | K221845 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Dental Taper Hex Implant Systems | K112875 | FDA 510(k) | Class II | Active |
| Modification To Blue Sky Dental Implant System | K021833 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Zygomatic Implant System | K190491 | FDA 510(k) | Class II | Active |
| Blue Sky Bio CAD-CAM Abutments | K202026 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Computerized Orthodontic Bracket System | K182338 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Dental Implant System | K073713 | FDA 510(k) | Class II | Active |
| Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | K232653 | FDA 510(k) | Class II | Active |
| Modification To Blue Sky Bio Dental Implant System | K051507 | FDA 510(k) | Class II | Active |
| Blue Sky Bio TAD | K201919 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Dental Implant System | K010882 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Zygomatic Implant System | K153064 | FDA 510(k) | Class II | Active |
| Modification To Blue Sky Bio Dental Implant System | K060957 | FDA 510(k) | Class II | Active |
| Drill For Blue Sky Bio Dental Implant System | K063874 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Dental Implant System | K102034 | FDA 510(k) | Class II | Active |
| Life Essence Universal Porcelain System | K163251 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Tcp | K110198 | FDA 510(k) | Class II | Active |
| Blue Sky Bio Aligner | K180107 | FDA 510(k) | Class II | Active |
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