Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1223843

FEI Number

1000305589

Entity Name

BICON, LLC

City/State/Country

Boston, MA, US

Establishment Address

501 Arborway, Boston, MA 02130, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bicon, LLC (Owner Number: 9010847)

Owner / Operator Contact Address

501 Arborway, --, Boston, MA 02130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050712

PMA Number

N/A

All Registered Proprietary Names

Polishing Kit IAC 6 x 8mm Implant WI-75 E/KM Original Bicon Dental Implant Syste Osteotome Hydroplastic Resin AEU-26BIC HybenX 4.5mm Implants - 8,11,14mm Lengths Bicon Implant Integra-Ti Integra-CP Tissue Punches Sulcus Reamer Chisel Osteotome Hand Reamer Seating Tip Bone Expander SynthoGraft 6 x 5.7mm Implant System Impulsion 4.5mm Guided Surgical Tray 5mm Guided Surgical Tray Comprehensive Instrumentation Tray 3mm Guided Surgical Tray 4mm Guided Surgical Tray Advanced Instrumentation Tray Restorative Instrumentation Tray TRINIA 5mm SHORT Implants Brevis Components Fixed-Detachable Components Locator Components Impression Copings Analogs TRINIA Pilot Drill Latch Reamer Gauges 3mm Narrow Bicon Implant System MAX 2.5 Implant System 5 x 6mm Implant System 4.5 x 6mm and 6 x 6mm Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2014-03-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2007-11-27
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2016-09-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-06-03
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2014-03-19
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2014-03-19
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2016-09-15
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2016-09-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-06-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-11-04
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2013-04-26
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2008-06-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-06-03
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2016-09-15
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-09-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2015-07-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-10-10
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2013-04-26
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2014-03-19
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2014-03-19
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2014-03-19
EJL	Bur, Dental	Dental	Class 1	872.3240	2013-04-26
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2013-04-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-10-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-10-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-10-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-06-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-06-03

Official Correspondent

VINCENT MORGAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bicon, 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 1223843. Last updated year: 2026. Please use registration number 1223843 when referencing this establishment in official correspondence.