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BLUE 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8476822688
PRRC Contact: Michele Kupcso
EUDAMED SRN: US-MF-000014016
FDA FEI Number: —
DUNS Number: 618960848

Catalogue (1705)

Page 26 of 35

Device	Model / Reference	Registries	Class	Status
Blue Sky Bio, LLC	IJHWT7011	FDA UDI	Class II	Active
Blue Sky Bio, LLC	IJHWT3708	FDA UDI	Class II	Active
Blue Sky Bio, LLC	ISQ4108	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	AABJHNPN	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	GLN3520	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	AOAW2565B	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	IJH3010	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	ABDSC10JHNP	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	IMU3013	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	Z9816C1	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	ASJHR03	FDA UDI	Class II	Active
Blue Sky Bio, LLC.	BIH45	FDA UDI	Class I	Active
BIO \| Cut Guide Tube 5.0 OD x 2.4 ID x 5mm L	TUBE5-24-5L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 3.0 OD x 2.3 ID x 5mm L	TUBE3-23-5L	EUDAMEDFDA UDI	Class I	Active
BIO \| Conus Implant Analog 4.5/5.0 Platform	BDH50	EUDAMEDFDA UDI	Class I	Active
Drill T 5.0mm Short	DRILLT50S	EUDAMEDFDA UDI	Class IIa	Active
Drill Guided Sinus Lift 3.6 x 7mm	DRILG-SD3607	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLT50S	CDRT50S	EUDAMEDFDA UDI	Class I	Active
Drill T 3.5mm Short	DRILLT35S	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 3.6 x 10mm	DRILG3610	EUDAMEDFDA UDI	Class IIa	Active
Drill N Implant 5.0 Long	DRILLN50L	EUDAMEDFDA UDI	Class IIa	Active
Drill Stop Starter Drill	DRILNSTPS	EUDAMEDFDA UDI	Class IIa	Active
Drill N Starter Long	DRILLNSL	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Guide Tube 4.0 OD x 2.4 ID x 5mm L	TUBE4-24-5L	EUDAMEDFDA UDI	Class I	Active
Bio \| Guide-Tube 5.7 OD x 4.7 ID x 4mm L	TUBE57-47-4L	EUDAMEDFDA UDI	Class I	Active
Guided Drill 2.5 x 16mm	DRILG2516	EUDAMEDFDA UDI	Class IIa	Active
GUIDED DRILL-Q, 4.3 x 6mm	DRILTG4306	EUDAMEDFDA UDI	Class IIa	Active
"Analog Implant Level Internal Octagon – Narrow	BON41	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 6.2 OD x 5 ID x 4mm L	TUBE62-5-4L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop-Q 3.5 x 6mm	DRILTSTP3506	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLT28S	CDRT28S	EUDAMEDFDA UDI	Class I	Active
Drill T 2.8mm Long	DRILLT28L	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 3.9 x 10mm	DRILNSTP3910	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube For Cer. M 4.27mm	TUBE53-427	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 6.1 OD x 5.1 ID x 6mm L	TUBE61-51-6L	EUDAMEDFDA UDI	Class I	Active
GUIDED DRILL-Q, 2.8 x 6mm	DRILTG2806	EUDAMEDFDA UDI	Class IIa	Active
Drill Guided Sinus Lift 3.6 x 3mm	DRILG-SD3603	EUDAMEDFDA UDI	Class IIa	Active
Drill Profile 3.5mm	DRILLP35	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 3.0 x 11.5mm	DRILNSTP3011	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLD36L	CDRD36L	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube Nobel Master Wide 6.09 OD x 5.13 ID	TUBE609-513	EUDAMEDFDA UDI	Class I	Active
GUIDED DRILL-Q, 2.2 x 6mm	DRILTG2206	EUDAMEDFDA UDI	Class IIa	Active
"Analog Implant Level Internal Octagon – Regular Platform	BOR48	EUDAMEDFDA UDI	Class I	Active
Bone Condenser 10/11	STPCND1011	EUDAMEDFDA UDI	Class I	Active
BIO \| Max Driver Variable Height NP	DTGJHNPVR	EUDAMEDFDA UDI	Class I	Active
Bone Condenser 2/3	STPCND23	EUDAMEDFDA UDI	Class I	Active
Guided Drill 2.0 x 11.5mm	DRILG2011	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Conus Implant Driver Ratchet 3.0 Platform Long	DTDH30L	EUDAMEDFDA UDI	Class I	Active
BIO \| Max Implant Analog RP	BIJHR	EUDAMEDFDA UDI	Class I	Active
Bio \| Guide-Tube 5.25 OD x 4.25 ID x 4mm L	TUBE525-425-4L	EUDAMEDFDA UDI	Class I	Active

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