Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003402534

FEI Number

3003402534

Entity Name

BLUE SKY BIO, LLC

City/State/Country

Libertyville, IL, US

Establishment Address

800 Liberty Drive, Libertyville, IL 60048, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BLUE SKY BIO, LLC (Owner Number: 9040515)

Owner / Operator Contact Address

800 Liberty Drive, Libertyville, IL 60048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K073713

PMA Number

N/A

All Registered Proprietary Names

Blue Sky Bio Plan Software - Crown and Bridge Module Blue Sky Plan Ortho Module Blue Sky Plan - IBT Module Blue Sky Bio Dental Implant System Blue Sky Plan Software Blue Sky Bio Dental Implant System - Bio / Conus Blue Sky Bio Pterygoid Implants and Abutments Zygomatic Implant System Blue Sky Bio Impression Blue Sky Bio Dental Implant System - One Piece Blue Sky Bio Dental Implant System - Internal Taper Blue Sky Bio Dental Implant System - Internal Octagon Taper Blue Sky Plan - Denture Module Blue Sky Bio CAD-CAM Abutments Blue Sky Bio Dental Implant System - Internal Hex Blue Sky Bio Dental Implant System - Tri-Lobe Blue Sky Bio Blue Sky Bio TAD Blue Sky Bio Dental Implant System - Double Hex 3 Platform Blue Sky Bio Dental Implant System - Octagon Regular and Wide Short

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2021-05-26
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-07-21
PNN	Orthodontic Software	Dental	Class 2	872.5470	2023-07-21
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2019-02-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-04-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2009-05-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-03-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-03-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-02-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-02-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-08-19
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2006-10-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-11-20
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2019-02-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-04-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-11-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-01-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-01-26
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2022-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-03-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-03-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-03-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-03-11

Official Correspondent

Michele Kupcso

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BLUE SKY BIO, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003402534. Last updated year: 2026. Please use registration number 3003402534 when referencing this establishment in official correspondence.