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 30 of 35

Device	Model / Reference	Registries	Class	Status
Analog Wide 4mm	BAW4000	EUDAMEDFDA UDI	Class I	Active
GUIDED KEY, 5.0mm OD, 2.0mm & 2.5mm DRILL	GK502025	EUDAMEDFDA UDI	Class I	Active
Drill Guided Sinus Lift 3.6 x 10mm	DRILG-SD3610	EUDAMEDFDA UDI	Class IIa	Active
GUIDED KEY, 6.2mm OD, 2.0mm & 2.5mm DRILL	GK622025	EUDAMEDFDA UDI	Class I	Active
BIO \| Internal Hex Implant Driver Ratchet Long	DTSBLIH	EUDAMEDFDA UDI	Class I	Active
Driver Hex .048 Short	SDS048	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 3.9 x 6mm	DRILNSTP3906	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLT43S	CDRT43S	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for 5mm Nob. Master 2.37mm	TUBE49-237	EUDAMEDFDA UDI	Class I	Active
Analog Level Internal Hex 3.5mm Platform	BIH35	EUDAMEDFDA UDI	Class I	Active
BIO \| Conus Implant Driver Handpiece 3.0 Long	DMDH30L	EUDAMEDFDA UDI	Class I	Active
Guided Drill 4.4 x 13mm	DRILG4413	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Guide Tube 6.9 OD x 6.2 ID x 4mm L	TUBE69-62-4L	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for 5mm Nob. Master 3.71mm	TUBE49-371	EUDAMEDFDA UDI	Class I	Active
Drill Profiler 3.2mm ID x 3.7mm OD	DRILLPR37	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Guide-Tube for Cer. S 2.98mm	TUBE44-298	EUDAMEDFDA UDI	Class I	Active
Drill D Implant 3.5 Long	DRILLD32L	EUDAMEDFDA UDI	Class IIa	Active
Drill D Starter Short	DRILLDSS	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Quattro Ratchet Implant Driver Short RP	DTSQR	EUDAMEDFDA UDI	Class I	Active
Guided Drill 3.9 x 13mm	DRILG3913	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop-Q 3.5 x 10mm	DRILTSTP3510	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLT35L	CDRT35L	EUDAMEDFDA UDI	Class I	Active
BIO \| Internal Hex Driver Variable Height	DTGIHVR	EUDAMEDFDA UDI	Class I	Active
Screw Remover	AFSR	EUDAMEDFDA UDI	Class I	Active
BIO \| Quattro Ratchet Implant Driver Long NP	DTLQN	EUDAMEDFDA UDI	Class I	Active
GUIDED DRILL-Q, 2.2 x 8mm	DRILTG2208	EUDAMEDFDA UDI	Class IIa	Active
Drill D 2.2mm Short	DRILLD22S	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 2.5 x 13mm	DRILNSTP2513	EUDAMEDFDA UDI	Class IIa	Active
Driver Hex .050 Long	SDL050	EUDAMEDFDA UDI	Class I	Active
BIO \| Max Implant Driver Handpiece NP Long	DMJHL	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for Cer. S 2.72mm	TUBE44-272	EUDAMEDFDA UDI	Class I	Active
Drill with Stop-Q 2.2 x 10mm	DRILTSTP2210	EUDAMEDFDA UDI	Class IIa	Active
Drill Profile D 35mm	DRILLPDH35	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Max Multiunit Implant Driver Ratchet	DTIMU	EUDAMEDFDA UDI	Class I	Active
BIO \| Guide-Tube for Cer. S 3.15mm	TUBE44-315	EUDAMEDFDA UDI	Class I	Active
Drill Guided Sinus Starter 3.6x2mm	DRILG-SD3602	EUDAMEDFDA UDI	Class IIa	Active
Drill N Implant 4.7 Long	DRILL4438L	EUDAMEDFDA UDI	Class IIa	Active
Analog Implant Level Internal Octagon – Wide Platform	BOW65	EUDAMEDFDA UDI	Class I	Active
Drill with Stop 4.6 x 11.5mm	DRILNSTP4611	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop-Q 2.8 x 6mm	DRILTSTP2806	EUDAMEDFDA UDI	Class IIa	Active
BIO \| Cut Shank Sleeve For DRILLT43L	CDRT43L	EUDAMEDFDA UDI	Class I	Active
Analog Regular 4mm	BAR4000	EUDAMEDFDA UDI	Class I	Active
BIO \| Cut Shank Sleeve For DRILLD32L	CDRD32L	EUDAMEDFDA UDI	Class I	Active
Guided Drill 3.6 x 16mm	DRILG3616	EUDAMEDFDA UDI	Class IIa	Active
Drill Profile H 4.1mm	DRILLPH41	EUDAMEDFDA UDI	Class IIa	Active
Drill Profile 5.0mm	DRILLP50	EUDAMEDFDA UDI	Class IIa	Active
Guided Drill 4.6 x 6mm	DRILG4606	EUDAMEDFDA UDI	Class IIa	Active
GUIDED DRILL-Q, 4.3 x 12mm	DRILTG4312	EUDAMEDFDA UDI	Class IIa	Active
Drill D Starter Long	DRILLDSL	EUDAMEDFDA UDI	Class IIa	Active
Drill with Stop 3.0 x 13mm	DRILNSTP3013	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.