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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 34 of 35

Device	Model / Reference	Registries	Class	Status
Guided Drill 2.0 x 6mm	DRILG2006	EUDAMEDFDA UDI	Class IIa	Active
Drill Profiler 3.2mm ID x 4.5mm OD	DRILLPR45	EUDAMEDFDA UDI	Class IIa	Active
BIO \| MAX Latch Driver Variable Height RP	DMGJHRPV	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube Nobel Master Wide 6.09 OD x 4.27 ID	TUBE609-427	EUDAMEDFDA UDI	Class I	Active
BIO \| Conus Implant Driver Ratchet 4.5/5.0 Long	DTDH50L	EUDAMEDFDA UDI	Class I	Active
BIO \| Max Implant Driver NP Ratchet Short	DTJHS	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.0 x 6mm	DRILNSTP3006	EUDAMEDFDA UDI	Class IIa	Active
Driver .080 Hex	DTHMU	EUDAMEDFDA UDI	Class I	Active
Drill N Implant 4.3 Short	DRILLN43S	EUDAMEDFDA UDI	Class IIa	Active
Bio \| Guide-Tube 7.2 OD x 6.2 ID x 3.5mm L	TUBE72-62-35L	EUDAMEDFDA UDI	Class I	Active
Drill T 4.3mm Short	DRILLT43S	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 2.0 x 10mm	DRILNSTP2010	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 3.9 x 11.5mm	DRILG3911	EUDAMEDFDA UDI	Class IIa	Active
Drill N Implant 7.0 Short	DRILL6653S	EUDAMEDFDA UDI	Class IIa	Active
Analog Tri-Lobe 3.5mm	BITT35	EUDAMEDFDA UDI	Class I	Active
Analog Multi Unit Abutment	BMU	EUDAMEDFDA UDI	Class I	Active
Bio \| Cut Guide Tube 5.1 OD x 4.1 ID x 3.5mm L	TUBE51-41-35L	EUDAMEDFDA UDI	Class I	Active
GUIDED KEY, 6.2mm OD, 3.0mm DRILL	GK623000	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for Cer. L 3.71mm	TUBE59-371	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube For 5mm Nob. Master 3.99mm	TUBE49-399	EUDAMEDFDA UDI	Class I	Active
GUIDED DRILL-Q, 3.5 x 8mm	DRILTG3508	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLD42S	CDRD42S	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 4.0 OD x 3.3 ID x 5mm L	TUBE4-33-5L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop-Q 2.8 x 10mm	DRILTSTP2810	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 3.6 x 6mm	DRILG3606	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube for Cer. L 4.68mm	TUBE59-468	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.9 x 13mm	DRILNSTP3913	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 3.9 x 16mm	DRILG3916	EUDAMEDFDA UDI	Class IIa	Active
Drill D Implant 4.0 Short	DRILLD36S	EUDAMEDFDA UDI	Class IIa	Active
Drill N Implant 5.0 Short	DRILLN50S	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 3.9 x 11.5mm	DRILNSTP3911	EUDAMEDFDA UDI	Class IIa	Active
Analog Regular 7mm	BAR7000	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 4.6 x 10mm	DRILNSTP4610	EUDAMEDFDA UDI	Class IIa	Active
Analog Regular 5.5mm	BAR5500	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 2.5 x 11.5mm	DRILNSTP2511	EUDAMEDFDA UDI	Class IIa	Active
Drill N 2.2mm Long	DRILLN22L	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Quattro Ratchet Driver Variable Offset RP	DTGSQRV	EUDAMEDFDA UDI	Class I	Active
BIO \| Quattro Ratchet Driver Variable Offset NP	DTGSQNV	EUDAMEDFDA UDI	Class I	Active
Drill N Implant 3.0 Short	DRILLN26S	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 2.0 x 8mm	DRILG2008	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Guide Tube 5.0 OD x 4.1 ID x 4mm L	TUBE5-41-4L	EUDAMEDFDA UDI	Class I	Active
Drill Profile H 4.7mm	DRILLPH47	EUDAMEDFDA UDI	Class IIa	Active
Bone Condenser 4/5	STPCND45	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 5.0 OD x 3.3 ID x 5mm L	TUBE5-33-5L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.0 x 16mm	DRILNSTP3016	EUDAMEDFDA UDI	Class IIa	Active
Analog Tri-Lobe 4.3mm	BITT43	EUDAMEDFDA UDI	Class I	Active
Drill Profiler 3.2mm ID x 6.5mm OD	DRILLPR65	EUDAMEDFDA UDI	Class IIa	Active
Bio \| Guide-Tube 6.15 OD x 5.15 ID x 4mm L	TUBE615-515-4L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 6.2 OD x 5.31 ID x 4.5mm L	TUBE62-531-45L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 2.5 x 10mm	DRILNSTP2510	EUDAMEDFDA UDI	Class IIa	Active

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