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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 29 of 35

Device	Model / Reference	Registries	Class	Status
Drill D Implant 3.0 Short	DRILLD26S	EUDAMEDFDA UDI	Class IIa	Active
Drill D Implant 3.0 Long	DRILLD26L	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 2.5 x 11.5mm	DRILG2511	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube for 5mm Nob. Master 4.27mm	TUBE49-427	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube 2.92mm	TUBE292	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube 2.31mm	TUBE231	EUDAMEDFDA UDI	Class I	Active
Drill Extender	TDE	EUDAMEDFDA UDI	Class I	Active
Bio \| Guide-Tube 3.0 OD x 2.0 ID x 4mm L	TUBE3-2-4L	EUDAMEDFDA UDI	Class I	Active
Bio \| Guide-Tube 2.6 OD x 1.6 ID x 4mm L	TUBE26-16-4L	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube 2.2mm	TUBE22	EUDAMEDFDA UDI	Class I	Active
Bio \| Guide-Tube 2.4 OD x 1.4 ID x 4mm L	TUBE24-14-4L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.6 x 8mm	DRILNSTP3608	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Quattro Handpiece Implant Driver Long RP	DMLQR	EUDAMEDFDA UDI	Class I	Active
Guided Drill 2.5 x 13mm	DRILG2513	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Max IJHWT Guided Driver Variable Height	DTGJHWTVR	EUDAMEDFDA UDI	Class I	Active
Drill N Implant 4.3 Long	DRILLN43L	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube for 5mm Nob. Master 3.28mm	TUBE49-328	EUDAMEDFDA UDI	Class I	Active
Drill D Implant 5.0 Long	DRILLD46L	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLT28L	CDRT28L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 2.5 x 8mm	DRILNSTP2508	EUDAMEDFDA UDI	Class IIa	Active
BIO \| One Stage Implant Driver Long	DT0018	EUDAMEDFDA UDI	Class I	Active
Guided Drill 2.5 x 6mm	DRILG2506	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Max Implant Driver RP Ratchet Long	DTJHRL	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 7.17 OD x 6.72 ID	TUBE717-672	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 4.0 OD x 2.3 ID x 5mm L	TUBE4-23-5L	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for 5mm Nob. Master 3.66mm	TUBE49-366	EUDAMEDFDA UDI	Class I	Active
GUIDED KEY, 5.0mm OD, 3.0mm DRILL	GK503000	EUDAMEDFDA UDI	Class I	Active
ITI Wrench Adapter	ITI-ADAPTER	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILLN35L	CDRN35L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 4.4 x 10mm	DRILNSTP4410	EUDAMEDFDA UDI	Class IIa	Active
Drill D 2.2mm Long	DRILLD22L	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Guide Tube 5.0 OD x 3.5 ID x 5mm L	TUBE5-35-5L	EUDAMEDFDA UDI	Class I	Active
Guided Drill 4.4 x 10mm	DRILG4410	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube 4.15mm	TUBE415	EUDAMEDFDA UDI	Class I	Active
Drill with Stop-Q 2.2 x 6mm	DRILTSTP2206	EUDAMEDFDA UDI	Class IIa	Active
Analog Narrow 4mm	BAN4000	EUDAMEDFDA UDI	Class I	Active
Drill T 3.5mm Long	DRILLT35L	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 4.4 x 8mm	DRILG4408	EUDAMEDFDA UDI	Class IIa	Active
Drill Profile D 5.0mm	DRILLPDH50	EUDAMEDFDA UDI	Class IIa	Active
Driver Hex .048 Long	SDL048	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILLD32S	CDRD32S	EUDAMEDFDA UDI	Class I	Active
Guided Drill 3.0 x 11.5mm	DRILG3011	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLD36S	CDRD36S	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for Cer. S 2.37mm	TUBE44-237	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for Cer. M 4.25mm	TUBE53-425	EUDAMEDFDA UDI	Class I	Active
BIO \| Conus Implant Driver Handpiece 3.5/4.0 Long	DMDH35L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILL4438S	CDR4438S	EUDAMEDFDA UDI	Class I	Active
BIO \| Conus Implant Driver Handpiece 4.5/5.0 Long	DMDH50L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 4.0 OD x 3.6 ID x 5mm L	TUBE4-36-5L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.9 x 8mm	DRILNSTP3908	EUDAMEDFDA UDI	Class IIa	Active

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