Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1424785

FEI Number

3003473212

Entity Name

ACCUMEDIX, INC.

City/State/Country

Libertyville, IL, US

Establishment Address

800 Liberty Drive, Libertyville, IL 60048, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ACCUMEDIX, INC. (Owner Number: 9046081)

Owner / Operator Contact Address

800 Liberty Drive, --, Libertyville, IL 60048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blue Sky Bio Dental Implant TrapEz SurePass CTR Blue Sky Bio Dental Bur Zygomatic Implant System Double Hex Implant System Blue Sky Bio Implant Accessories Pinkband Dental Band Flycast Technologies Dental Band Zygomatic Implant System Novilase Laser Therapy System and Novilase Breast ILT Packs Blue Sky Bio Pterygoid Implants and Abutments Blue Sky Bio Impression Copings Osteomedix Bone Particle Collector Bio Conus, Bio Max, and Bio Quattro Implant Systems Breast Shells 36mm (12 pack) Steril Kit D26 - 10 Pack Sterile Kit D26 Calypso To Go Pure TX NightWare Blue Sky Bio Dental Implant NovoSort; ProteX; ProteX Safe-Seal SURGICAL CURETTE Amaryll Essentials (10 pack) Dental Implant Accessory Instruments Blue Sky Bio CAD-CAM Abutments Blue Sky Bio Dental Implant HOTWIRE RF Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-04-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-03-25
EJL	Bur, Dental	Dental	Class 1	872.3240	2009-12-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-02-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-02-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-02-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2008-11-12
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2018-11-07
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2008-11-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-02-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-02-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-05
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
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2009-12-26
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2018-11-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-02-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-02-09
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-03-30
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-03-31
QMZ	Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions	Neurology	Class 2	882.5705	2021-01-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-04-21
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2023-09-11
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-08-21
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2022-03-31
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2021-02-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-04-26
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-07-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-12-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-12-26
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2024-06-20

Official Correspondent

Michele Kupcso

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACCUMEDIX, INC.

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 1424785. Last updated year: 2026. Please use registration number 1424785 when referencing this establishment in official correspondence.