Blue Sky Bio, LLC.

FDA UDI

Class II (US FDA UDI)

by Blue Sky Bio Llc

Identity

Trade Name: Blue Sky Bio, LLC. FDA UDI
Generic Name: Dental treatment application software FDA UDI
Model / Reference: Blue Sky Plan Software FDA UDI

Identifiers

Primary DI / UDI-DI: 00815131026412 FDA UDI
510(k) Number: K090607 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Dental treatment application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental treatment application software

Blue Sky Bio, LLC. by Blue Sky Bio Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental treatment application software.

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ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth Segmentation — Zirkonzahn GmbH · Class II
OsstellConnect — Osstell AB · Class I
iChiropro Surgery APP — Bien-Air Dental SA · Class I
Swissmeda Dental Planning System — Swissmeda AG · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Blue Sky Bio Llc

Sources (1)

FDA UDI c2bb9df9-84ba-4c2c-a446-048ecee7943c 33 fields · synced Jun 8, 2026