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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 28 of 35

Device	Model / Reference	Registries	Class	Status
Blue Sky Bio Plan, Version .38	K090607	FDA 510(k)	Class II	Active
Synthetic Glass Bone Graft Material	K000633	FDA 510(k)	Class II	Active
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments	K212785	FDA 510(k)	Class II	Active
BIO \| Guide-Tube For 5mm Nob. Master 3.15mm	TUBE49-315	EUDAMEDFDA UDI	Class I	Active
Bio \| Cut Guide Tube 5.24 OD x 5.04 ID x 4mm L	TUBE524-504-4L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILLD46L	CDRD46L	EUDAMEDFDA UDI	Class I	Active
BIO \| MAX Latch Driver Variable Height NP	DMGJHNPV	EUDAMEDFDA UDI	Class I	Active
Guided Drill 3.9 x 6mm	DRILG3906	EUDAMEDFDA UDI	Class IIa	Active
Bio \| Guide-Tube 2.55 OD x 1.55 ID x 7mm Flangeless	TUBE255-155-7NL	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 4.4 x 13mm	DRILNSTP4413	EUDAMEDFDA UDI	Class IIa	Active
Bio \| Guide-Tube 2.2 OD x 1.2 ID x 4mm L	TUBE22-12-4L	EUDAMEDFDA UDI	Class I	Active
S6 Screw Driver, .065 Star Ratchet Screw Driver, Short	SDSQS	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.9 x 16mm	DRILNSTP3916	EUDAMEDFDA UDI	Class IIa	Active
Bio \| Guide-Tube 6.25 OD x 5.25 ID x 4mm L	TUBE625-525-4L	EUDAMEDFDA UDI	Class I	Active
BIO \| Quattro Handpiece Implant Driver Long NP	DMLQN	EUDAMEDFDA UDI	Class I	Active
Guided Drill 3.9 x 10mm	DRILG3910	EUDAMEDFDA UDI	Class IIa	Active
Drill N Implant 4.1 Short	DRILL3630S	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLD46S	CDRD46S	EUDAMEDFDA UDI	Class I	Active
BIO \| Quattro Handpiece Implant Driver Short NP	DMSQN	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube 2.11mm	TUBE211	EUDAMEDFDA UDI	Class I	Active
UNI Driver Short	SDUGS	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 6.5 OD x 5.5 ID x 4mm L	TUBE65-55-4L	EUDAMEDFDA UDI	Class I	Active
Drill Guided Sinus Lift 3.6 x 4mm	DRILG-SD3604	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop-Q 2.8 x 8mm	DRILTSTP2808	EUDAMEDFDA UDI	Class IIa	Active
Drill Profile H 3.7mm	DRILLPH37	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Quattro Ratchet Implant Driver Long RP	DTLQR	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.6 x 10mm	DRILNSTP3610	EUDAMEDFDA UDI	Class IIa	Active
Drill D Implant 4.0 Long	DRILLD36L	EUDAMEDFDA UDI	Class IIa	Active
Analog Level Internal Hex 4.5mm Platform	BIH45	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube 4.25mm	TUBE425	EUDAMEDFDA UDI	Class I	Active
BIO \| Quattro Handpiece Implant Driver Short RP	DMSQR	EUDAMEDFDA UDI	Class I	Active
Drill T 2.2mm Short	DRILLT22S	EUDAMEDFDA UDI	Class IIa	Active
Drill N Starter Short	DRILLNSS	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 3.0 x 10mm	DRILG3010	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLN43L	CDRN43L	EUDAMEDFDA UDI	Class I	Active
Drill N Implant 5.7 Short	DRILLH53S	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube 6.0 OD x 5.06 ID x 3.5mm L	TUBE6-506-35L	EUDAMEDFDA UDI	Class I	Active
Guided Drill 4.6 x 13mm	DRILG4613	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Guide Tube 6.95 OD x 6.13 ID x 3.2mm L	TUBE695-613-32L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 5.27 OD x 4.35 ID x 6mm L	TUBE527-435-6L	EUDAMEDFDA UDI	Class I	Active
BIO \| Max Implant Driver Handpiece RP Short	DMJHRS	EUDAMEDFDA UDI	Class I	Active
BIO \| MAX RP Guided Ratchet Driver	DTGJHRPV	EUDAMEDFDA UDI	Class I	Active
Analog Narrow 5.5mm	BAN5500	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 3.0 OD x 2.1 ID x 5mm L	TUBE3-21-5L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILLN50L	CDRN50L	EUDAMEDFDA UDI	Class I	Active
Drill Guided Sinus Lift 3.6 x 11mm	DRILG-SD3611	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 4.4 x 16mm	DRILNSTP4416	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop-Q 2.2 x 12mm	DRILTSTP2212	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Max Multiunit Angled Implant Driver Ratchet	DTAIMU	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILL4438L	CDR4438L	EUDAMEDFDA UDI	Class I	Active

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