Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808227

FEI Number

3002808227

Entity Name

SOR VAN RADIATION LTD

City/State/Country

Yavne Tel Aviv, IL

Establishment Address

Kiryat Soreq, POB 214, Yavne Tel Aviv 81800, IL

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Sor Van Radiation Ltd (Owner Number: 10042358)

Owner / Operator Contact Address

Kiryat Soreq, POB 214, Yavne, IL-TA 81800, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

API - Advanced Precision Implant ULT - Ultimate Precision Implant Slider Nitinol Shuttle Nitinol Loop Passer Morpheus 8 12 pin tip Morpheus 8 T tip Morpheus 8 40 pin tip Morpheus 8 24 pin tip IDEAL Suture Shuttle Slider Needle Morpheus 8 T tip Morpheus 8 12 pin tip Fractora 60 pin tip Fractora 3D/3D-90 Morpheus 8 24 pin tip Fractora FRF tip Morpheus 8 40 pin tip ProMIS Extension Rod System OSSIO Punch OSSIO Tap Pack Set, i.V. Fluid transfer InModeRF Applicator ProMIS Fixation System Eclipse PRP; Qigeneration TropoCells Autologous Platelet Preparation Kit VasQ Set, i.V. Fluid transfer OSSIO Drill bit & Drill Guide OSSIO Drill Pack OSSIO Drill bit OSSIO Drill bit & Drill Guide Pack OSSIO Staple Sizing Guide Morpheus 8 12 pin tip Fractora 3D/3D-90 Fractora FRF tip Fractora 60 pin tip Morpheus 8 T tip Morpheus 8 24 pin tip Morpheus 8 40 pin tip Set, i.V. Fluid transfer InModeRF Applicator Agili-C Mini Disposable Toolset Set, i.V. Fluid transfer Fractora 60 pin tip InModeRF Applicator CPI - Cylindrical Precision Implant OPI - One Piece Implant MPI - Molecular Precision Implant Fractora 3D/3D-90 Morpheus 8 12 pin tip Fractora FRF tip Morpheus 8 T tip Morpheus 8 24 pin tip Morpheus 8 40 pin tip Fractora 60 pin tip Sterile Disposables for MER EVICEL 45 cm Applicator Tip EVICEL 35 cm Applicator Tip EVICEL Modular Application Device (1 & 2 ml) EVICEL Modular Application Device (5 ml) Agili-C Set, i.V. Fluid transfer Set, i.V. Fluid transfer OSSIO Orthopedic Staple Instrument Pack Fractora FRF tip TLI- Tissue Level Precision Implant Set, i.V. Fluid transfer CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM WoundClot Hemostatic Gauze Massif Implants Crestone Implants Axis Implants CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Woundclot NIO Infant Set, i.V. Fluid transfer Morpheus 8 40 pin tip Morpheus 8 12 pin tip Morpheus 8 T tip Morpheus 8 24 pin tip VersaLink Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-10-26
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2015-07-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
HWQ	Passer	Orthopedic	Class 1	888.4540	2015-07-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-05
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-12-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-05-28
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-05-24
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-05-23
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-05-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2024-05-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-05-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-05-28
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-08-11
QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access	Cardiovascular	Class 2	870.4600	2024-02-19
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-06-03
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-05-24
HWT	Template	Orthopedic	Class 1	888.4800	2023-11-07
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-12-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-05
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-12-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-05
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-05-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Orthopedic	Class 2	888.4505	2025-08-19
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-06-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-10-26
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	Class 2	878.4400	2022-12-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-05
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	Class 2	878.4810	2022-12-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2020-01-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-09-25
QRU	Implant, Resorbable, For Articular Osteochondral Repair	Unknown	Class 3	N/A	2025-08-19
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-06-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-06-03
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-11-18
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2022-12-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2026-05-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-05-23
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-06-03
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2020-01-07
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2020-01-07
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2022-08-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-06-30
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-06-30
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2020-01-07
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2022-08-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-01-25
MHC	Needle, Interosseous	General Hospital	Class 2	880.5570	2020-01-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-05-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-05-28

Official Correspondent

George Hattub

US Agent Details

George Hattub Business: Medicsense USA Email: ghattub@comcast.net Phone: (508) 4796116

Related Public Records

Same Entity

Sor Van Radiation 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808227. Last updated year: 2026. Please use registration number 3002808227 when referencing this establishment in official correspondence.