Is this your brand? Sign in to claim ownership.

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 32 of 35

Device	Model / Reference	Registries	Class	Status
Drill with Stop-Q 4.3 x 10mm	DRILTSTP4310	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube for 5mm Nob. Master 2.98mm	TUBE49-298	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.6 x 11.5mm	DRILNSTP3611	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 4.6 x 6mm	DRILNSTP4606	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILL3630L	CDR3630L	EUDAMEDFDA UDI	Class I	Active
BIO \| Max Implant Analog NP	BIJH	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 4.6 x 13mm	DRILNSTP4613	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 4.4 x 6mm	DRILG4406	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 3.0 x 8mm	DRILG3008	EUDAMEDFDA UDI	Class IIa	Active
GUIDED DRILL-Q, 4.3 x 10mm	DRILTG4310	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Guide Tube 5.0 OD x 2.3 ID x 5mm L	TUBE5-23-5L	EUDAMEDFDA UDI	Class I	Active
Drill N Implant 3.5, 3.7 Long	DRILLN35L	EUDAMEDFDA UDI	Class IIa	Active
GUIDED DRILL-Q, 2.8 x 10mm	DRILTG2810	EUDAMEDFDA UDI	Class IIa	Active
GUIDED DRILL-Q, 2.8 x 12mm	DRILTG2812	EUDAMEDFDA UDI	Class IIa	Active
Lance Drill 150	LD150	EUDAMEDFDA UDI	Class I	Active
Drill T Starter Long	DRILLTSL	EUDAMEDFDA UDI	Class IIa	Active
Drill D Implant 4.5 Short	DRILLD42S	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 3.6 x 16mm	DRILNSTP3616	EUDAMEDFDA UDI	Class IIa	Active
Bio \| Guide-Tube 3.4 OD x 2.4 ID x 4mm L	TUBE34-24-4L	EUDAMEDFDA UDI	Class I	Active
BIO \| Conus Implant Driver Handpiece 3.0 Short	DTDH30S	EUDAMEDFDA UDI	Class I	Active
BIO \| Conus Implant Driver Handpiece 3.0 Short	DMDH30S	EUDAMEDFDA UDI	Class I	Active
Driver Hex .050 Short	SDS050	EUDAMEDFDA UDI	Class I	Active
Guided Drill 4.6 x 10mm	DRILG4610	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Guide Tube 3.0 OD x 2.4 ID x 5mm L	TUBE3-24-5L	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 5.0 OD x 2.8 ID x 5mm L	TUBE5-28-5L	EUDAMEDFDA UDI	Class I	Active
Guided Drill 2.0 x 16mm	DRILG2016	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube 3.68mm	TUBE368	EUDAMEDFDA UDI	Class I	Active
BIO \| Internal Hex Implant Driver Ratchet Short	DTSBSIH	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Guide Tube 6.7 OD x 5.7 ID x 4mm L	TUBE67-57-4L	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.6 x 6mm	DRILNSTP3606	EUDAMEDFDA UDI	Class IIa	Active
Drill D Implant 3.5 Short	DRILLD32S	EUDAMEDFDA UDI	Class IIa	Active
Analog Wide 5.5mm	BAW5500	EUDAMEDFDA UDI	Class I	Active
Bone Condenser 8/9	STPCND89	EUDAMEDFDA UDI	Class I	Active
Flat Milling	DRILGFLAT	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Quattro Latch Driver Variable Offset NP	DMGSQNV	EUDAMEDFDA UDI	Class I	Active
GUIDED DRILL-Q, 3.5 x 12mm	DRILTG3512	EUDAMEDFDA UDI	Class IIa	Active
Analog Tri-Lobe 5.0mm	BITT50	EUDAMEDFDA UDI	Class I	Active
Drill with Stop-Q 2.8 x 12mm	DRILTSTP2812	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop-Q 4.3 x 6mm	DRILTSTP4306	EUDAMEDFDA UDI	Class IIa	Active
S6 Screw Driver, .065 Star Ratchet Screw Driver, Long	SDSQL	EUDAMEDFDA UDI	Class I	Active
Bio \| Cut Guide Tube 5.24 OD x 5.04 ID x 4mm LNF	TUBE524-504-4LNF	EUDAMEDFDA UDI	Class I	Active
Bio \| Cut Guide Tube 6.9 OD x 5.9 ID x 4mm L	TUBE69-59-4L	EUDAMEDFDA UDI	Class I	Active
BIO \| Quattro RP Implant Mount SS	MOUNTSQRP-S	EUDAMEDFDA UDI	Class I	Active
Bio \| Guide-Tube 6.35 OD x 5.35 ID x 4mm L	TUBE635-535-4L	EUDAMEDFDA UDI	Class I	Active
Drill Profile D 4.5mm	DRILLPDH45	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube for 5mm Nob. Master 4.42mm	TUBE49-442	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILLD42L	CDRD42L	EUDAMEDFDA UDI	Class I	Active
Guided Drill 3.0 x 6mm	DRILG3006	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 4.4 x 6mm	DRILNSTP4406	EUDAMEDFDA UDI	Class IIa	Active
GUIDED DRILL-Q, 3.5 x 10mm	DRILTG3510	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

mdi Europa GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.