Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021630667

FEI Number

3021630667

Entity Name

NOGA MEDICAL PRODUCTS LTD.

City/State/Country

SHLOMI Northern, IL

Establishment Address

HAKRIYA 1, SHLOMI Northern 2283200, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NOGA MEDICAL PRODUCTS LTD. (Owner Number: 10086141)

Owner / Operator Contact Address

HAKRIYA 1, SHLOMI, IL-Z 2283200, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143326

PMA Number

N/A

All Registered Proprietary Names

Crestone One Piece Implant ø3.50 L16mm CAD CAM Ti Base CC Esthetic Abutment H2mm Ti RobiCone Implant ø5 L8mm CC Direct CoCr Plastic Cylinder With Hex. W6mm RobiCone Implant ø3.30 L10mm Axis Implant ø5 L10mm CC Narrow Abutment H0mm CC CAD/CAM Ti Base H2mm CC Temporary Abutment H3mm PEEK CC Equator Abutment H4mm CC Direct CoCr Plastic Cylinder With Hex. W10mm CC Multi-Unit H5mm CAD CAM Ti Base H1mm Round Standard Healing Cap 3mm RobiCone Implant ø3.75 L16mm CC Narrow Solid Abutment H0mm CC Anatomic Abutment H2mm L6mm Wide CC Equator Attachment H1mm RobiCone Implant ø6 L8mm Axis Implant ø3.75 L13mm Axis Implant ø3.75 L16mm CC Multi-Unit 17 H2mm CC 15 Temporary Abutment H1mm PEEK CC 25 Temporary Abutment H3mm PEEK RobiCone Implant ø5 L13mm CAD CAM Low Temporary M.U Ti Cementing Post Axis Implant ø3.75 L11.50mm CC Equator Attachment H2mm CC Ball Attachment H1mm RobiCone Implant ø4.20 L10mm CC Anatomic Abutment H4mm L6mm Wide CAD CAM Temporary Ti Cementing Post CC Titanium Universal Abutment CC 15 Angulated Abutment H2mm Ti Wide CC CAD/CAM Temporary Peek Cementing Post CC CAD/CAM Ti Base H1mm Round CC Direct Ti Plastic Cylinder With Hex. Axis Implant ø4.20 L16mm CC 25 Angulated Abutment RobiCone Implant ø6 L10mm CC Ball Attachment H3mm CC 25 Esthetic Abutment H3mm Ti Direct CoCr Plastic Abutment Cylinder Hex. Axis Implant ø6 L13mm CC 15 Esthetic Abutment H1mm Ti CC Anatomic Restoration Kit H3mm L4mm Wide Healing Cap 2mm Crestone One Piece Implant ø3 L11.50mm Axis Implant ø5 L8mm CC Ball Attachment H2mm CC Equator Attachment H5mm CC Ball Attachment 17 H3mm CC Anatomic Restoration Kit H4mm L6mm Axis Implant ø3.75 L10mm CAD CAM Ti Base H2mm Round CC Ball Attachment H4mm Wide Healing Cap 4mm CC CAD/CAM Ti Base H2mm Round Ball Attachment 30 4mm CC Anatomic Restoration Kit H2mm L6mm Standard Healing Cap 6mm CC CAD/CAM Ti Base Round CC Anatomic Restoration Kit H3mm L6mm Axis Implant ø3.30 L10mm CAD CAM Low Ti Base for Multi Unit Crestone One Piece Implant ø3.50 L13mm Crestone One Piece Implant ø3 L13mm Crestone One Piece Implant ø3 L16mm CC Anatomic Restoration Kit H1mm L4mm Standard Healing Cap 2mm CC Anatomic Abutment H3mm L6mm CC Esthetic Abutment H3mm Ti CC Multi-Unit 17 H3mm CC Multi-Unit 17 H4mm CC CAD/CAM Ti Base CC Anatomic Abutment H5mm L6mm CC 25 Narrow Abutment H0mm SIC Ti Base Kit CC Anatomic Abutment H3mm L6mm Wide CC Multi-Unit 30 H2mm CC Direct Gold Plastic Cylinder Round CC Ball Attachment 30 H4mm CC Ball Attachment 30 H2mm SIC Cup CC Direct CoCr Plastic Cylinder With Hex. CC 15 Esthetic Abutment H2mm Ti CC CAD/CAM Blank 9 CC Direct Plastic Cylinder With Hex. W10mm CAD CAM Ti Base Round CC Anatomic Restoration Kit H3mm L8mm CC Equator Abutment H3mm CC 25 Esthetic Abutment H1mm Ti Axis Implant ø5 L11.50mm CC Anatomic Restoration Kit H5mm L4mm CC Anatomic Abutment H5mm L6mm Wide RobiCone Implant ø3.30 L11.50mm CC Anatomic Abutment H2mm L6mm Tag Dental Massif Implant ø3.75 L8mm RobiCone Implant ø6 L13mm CC CAD/CAM Blank 12 CC 15 Angulated Abutment CC 15 Temporary Abutment H2mm PEEK Direct CoCr Plastic Abutment Cylinder Round RobiCone Implant ø4.20 L8mm CC Ball Attachment 17 H2mm CC Temporary Abutment H2mm PEEK RobiCone Implant ø3.75 L10mm Massif Implant ø3.75 L10mm CC CAD/CAM Temporary Ti Cementing Post CC Anatomic Restoration Kit H1mm L8mm CC Equator Abutment H1mm CAD CAM Ti Base H1mm Axis Implant ø6 L10mm CC Multi-Unit H2mm CC 25 Esthetic Abutment H2mm Ti RobiCone Implant ø4.20 L11.50mm Standard Healing Cap 5mm CC Direct Plastic Cylinder With Hex. W6mm CAD CAM Temporary Multi Unit Ti Cementing Post CC Anatomic Abutment H4mm L8mm Axis Implant ø3.30 L13mm CC CAD/CAM Ti Base H3mm Round CC Anatomic Abutment H5mm L8mm RobiCone Implant ø5 L11.50mm Crestone One Piece Implant ø3.50 L10mm Axis Implant ø4.20 L13mm CC 15 Narrow Abutment H0mm CC Anatomic Restoration Kit H5mm L8mm CC Direct Gold Plastic Cylinder With Hex. W10mm CC 25 Angulated Abutment H2mm Ti Wide CC Anatomic Restoration Kit H4mm L4mm CAD CAM Ti Base H3mm Round RobiCone Implant ø3.75 L11.50mm CC Anatomic Restoration Kit H2mm L8mm CC Anatomic Abutment H1mm L8mm CC Anatomic Abutment H1mm L6mm CC Anatomic Abutment H1mm L4mm CC Direct Ti Plastic Cylinder With Hex. W6mm CAD CAM Temporary Peek Cementing Post CC Multi-Unit H1mm CC Anatomic Abutment H2mm L4mm CC Anatomic Abutment H4mm L4mm CC Universal Abutment H0mm Standard Healing Cap 4mm CAD CAM Ti Base H2mm RobiCone Implant ø4.20 L16mm CC 15 Esthetic Abutment H3mm Ti Wide Healing Cap 6mm CC Anatomic Restoration Kit H4mm L8mm CC Equator Attachment H4mm Axis Implant ø4.20 L11.50mm CAD CAM Ti Base H3mm CC CAD/CAM Ti Base H1mm CC 25 Temporary Abutment H1mm PEEK CC Multi-Unit H4mm CC Esthetic Abutment H1mm Ti RobiCone Implant ø3.30 L16mm CAD CAM Temporary Multi Unit Peek Cementing Post CC Direct Ti Plastic Cylinder With Hex. W10mm CC Equator Abutment H5mm CC Ball Attachment H5mm Wide Healing Cap 5mm CC Anatomic Abutment H3mm L8mm CC Anatomic Abutment H5mm L4mm CC Anatomic Abutment H2mm L8mm CC Direct Gold Plastic Cylinder With Hex. W6mm RobiCone Implant ø3.75 L8mm CC Anatomic Restoration Kit H5mm L6mm Axis Implant ø3.30 L11.50mm Crestone One Piece Implant ø3 L10mm CC Equator Abutment H2mm CC Multi-Unit 30 H3mm CC CAD/CAM Ti Base H3mm CC Direct Gold Plastic Cylinder With Hex. Axis Implant ø3.75 L8mm Axis Implant ø6 L11.50mm SIC Ti Base CC Anatomic Restoration Kit H2mm L4mm CC 25 Temporary Abutment H2mm PEEK CC 15 Temporary Abutment H3mm PEEK Crestone One Piece Implant ø3.50 L11.50mm Axis Implant ø4.20 L8mm CAD CAM Ti Base for Multi Unit RobiCone Implant ø4.20 L13mm CC Ball Attachment 30 H3mm Axis Implant ø4.20 L10mm Ball Attachment 17 4mm RobiCone Implant ø3.75 L13mm RobiCone Implant ø6 L11.50mm CC Direct Plastic Cylinder Round Wide Healing Cap 3mm CC Direct Plastic Cylinder With Hex. CC Ball Attachment 17 H4mm RobiCone Implant ø3.30 L13mm CC Multi-Unit H3mm CC Equator Attachment H3mm Axis Implant ø5 L13mm CC Universal Ti Abutment Wide CC Direct CoCr Plastic Cylinder Round CC Direct Ti Plastic Cylinder Round CC Anatomic Restoration Kit H1mm L6mm CC Anatomic Abutment H4mm L6mm Axis Implant ø3.30 L16mm Axis Implant ø6 L8mm CC Anatomic Abutment H3mm L4mm CC Temporary Abutment H1mm PEEK RobiCone Implant ø5 L10mm CC Multi-Unit 30 H4mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2022-10-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-10-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-10-18

Official Correspondent

Shirly Gaisin

US Agent Details

Stephen Inglese Business: PRI Dental Email: swi@qss-llc.com Phone: (561) 2510876

Related Public Records

Same Entity

NOGA MEDICAL PRODUCTS LTD.

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 3021630667. Last updated year: 2026. Please use registration number 3021630667 when referencing this establishment in official correspondence.