ENDONEST MEDICAL SYSTEMS LLP

FDA Device Registration & Listing · PALGHAR Maharashtra, IN · Registration 3030516433

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030516433
FEI Number
3030516433
Entity Name
ENDONEST MEDICAL SYSTEMS LLP
City/State/Country
PALGHAR Maharashtra, IN
Establishment Address
GALA NO 111, BLDG NO 23, HDIL INDUSTRIAL PARK, CHANDANSAR, VASAI VIRAR, PALGHAR Maharashtra 401305, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ENDONEST MEDICAL SYSTEMS LLP (Owner Number: 10090090)
Owner / Operator Contact Address
212, 2nd Floor Patparganj Industrial Area Delhi 110092, Patparganj, IN-DL 110092, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EndoNest Peadiatric Bed, (EN66P-1001)(EN66P-1002)(EN66P-1003)(EN66P-1004)(EN66P-1005)(EN66P-1006)(EN66P-1007) EndoNest MONITOR, EndoNest BED PATIENT, EndoNest Medical Grade Monitor, EndoNest non Medical Monitor EndoNest monitor , EndoNest Multi Pera Monitor, EndoNest 5 Para Monitor EndoNest 3 Para Monitor(EN11-1001)(EN11-1002)(EN11-1003)(EN11-1004)(EN11-1005) Instrument, Ligature Passing And Knot Tying - KNOT TYING INSTRUMENT *V*; EndoNest LIGATURE PASSING; For Fascial Closure, Fasical Closure, Gun type (EN21-725) , (EN21-726,en21-726A,EN21-727) EndoNest LIGATURE PASSING AND Instrument, EndoNest Ligature Passing And Knot Tying - EndoNest Needle TC Needle Holder , EndoNest open surgery TC Instruments (EN21-728)(EN21-729) (EN03-1018)(EN03-1019)(EN03-1020)(EN03-1021)(EN03-1022)(EN03-1023)(EN03-1024) )(EN03-1008)(EN03-1009)(EN03-1010)(EN03-1011)(EN03-1012)(EN03-1013)(EN03-1014)(EN03-1015)(EN03-1016)(EN03-1017) Laparoscopy Pump , Irrigation pump , (EN03-1001),(EN03-1002)(EN03-1003)(EN03-1004)(EN03-1005)(EN03-1006)(EN03-1007) EndoNest ocular surgery Infusion Pump, Endonest Syringe Pump , Suction Irrigation, ECG Machine, Suction irigation pump LED LIGHT SOURCE EN16-2044/ 2040 /2044-300, EN-1649 EndoNest 100 w , endonest 150w, EndoNest 175w EN23-103 Emergency Trolley; EN23-104 Emergency Trolly; EN23-105 Bedside Cabinet Gray and Blue EN23-114 Medicine Trolly, Laparoscopy Trolley ,EndoNest endoscopic Trolley EN23-109 EndoNest Overbed Table, Wooden Trim; EN23-110 Overbed Tabler, Gray color EN23-111 Pole;EN23-112 IV Pole S.S. 304; EN23-113 Medicine Trolley EN23-106 Bedside Cabinet;EN23-107 Overbed Table; EN23-108 Bedside Cabinte, Wooden Trim EndoNest EN23-100 Case-History Trolley; EEndoNest N23-101 Case-History Trolley; EN23-102 Emergency Trolly; EndoNest Components, EndoNest Wheelchair,EndoNest O.T Chair , EndoNest O.T Products , EndoNest Furnitures (EN62-1001,EN62-1002,EN62-1003,EN62-1004,EN62-1005,EN62-1006,EN62-1007,EN62-1008,EN62-1009,EN62-1xxx----EN62-2000) EndoNest Dental Instruments, EndoNest Roungers' EN55-2001-------EN56-1000) EndoNest Dental ACCESSORIES, EndoNest IMPLANT, EndoNest DENTAL,EndoNest ENDOSSEOUS, EndoNest Power Table Model; EndoNest Power Table Model AV 220; Power Table Model AV 240; EndoNest Power Table (EN18400)(EN18401)(EN18402)(EN18403)(EN18404)(EN18405)(EN18406) EndoNest Table, EndoNest Instrument table, EndoNest Powered, EndoNest Ophthalmic - Power Table Model; Surgical shadowless operation Theatre light ceiling, fill,GI/PPGI/SS/HPL); Modular single arm pendant, (Normal/Pneumatic) Modular double arm pendant; Single arm anesthetic Pendant, Endonest Double arm anesthetic Pendant, Modular fixed pendant; pendant; Bed head panel (HORIZONTAL), Endonest Bed head panel (VERTICAL), OT Swing door,Endonest Automatic sliding Endonest (Normal/Pneumatic) Endonest Modular electric single arm pendant, Endonest Modular electric double arm Hepa housing, WALL GARD, CORNER GARD; Endonest Manual sliding door, Wall and ceiling panel (puf or honeycomb LIGHT, SURGICAL, EndoNest CEILING MOUNTED door; Fixed Surgical Pendant, Single arm Surgical Pendant, Double arm Surgical Pendant, Fixed anesthetic pendant; Laminar air flow; Wall and ceiling panel (glass), Hermatic seal swing door, Pressure relief damper EndoNest MICROSCOPE, EndoNest SURGICAL, EndoNest GENERAL & PLASTIC SURGERY (EN23-2002)(EN33-2006)(EN24-2006) EndoNest Flexible and rigid ureterotome system(EN21-2001), EndoNest Flexible URS Flexible Colonoscope, EndoNest Flexible Gesteroscope , Flexible Broncoscope, Flexible ERCP, Flexible Endo Urology, EndoNest ENDOSCOPY RESECTOSCOPE ACCESSORIES; RESECTOSCOPE; EndoNest WORKING ELEMENT(EN23-2001) Flexible Endscopy Cup, Menstrual- Vaccum Delivery machine Retractors, EndoNest Tissue Forceps, EndoNest Graspers (EN12-10001)(EN12-10002)(EN12-10003) surgical instruments, g-u, manual (and accessories) EndoNest Hermorrhoidal Forceps,EndoNest Open Surgery Instruments All Types , EndoNest Forceps , EndoNest Scissors EndoNest FORCEPS, EndoNest GENERAL & PLASTIC SURGERY Co2 Accessories , EndoNest smoke Evaculator ( EN2060-SE)( EN2050-SE)( EN2040-SE)( EN2030-SE) EndoNest Insufflator(EN-2060-30,EN-2060-40,EN-2060-50)(EN-2060-30T,EN-2060-40T,EN-2060-50T) EndoNest EndoCarbon (EN2061-30/40/50) (EN2061-30T/40T/50T) EndoNest Laparoscopic(EN-2060-30H,EN-2060-40H,EN-2060-50H) EndoNest Laryngoscope, EndoNest Non-Rigid Flexible (EN03-001,EN03-003,EN03-004) EndoNest Endoscopic Grasping/Cutting Instrument, Sealer instruments EndoNest Trocars & Accessories Grasper, EndoNest Bipolar Grasper, EndoNest Cables, EndoNest Veress Needle EndoNest Laparoscope-, EndoNest Laparoscopy hand instruments, EndoNest Laparoscopy Hand Instruments all types EndoNest Gynecologic, EndoNest Mayoma, EndoNest Marwa Manbipulator, EndoNest Mangeshkar Manipulator EndoNest Laparoscopic Accessories, EndoNest Gynecologic - EndoNest Laparoscopic Accessories EndoNest v Type Manipulator ,EndoNest Storz Type Manipulator (EN21-3100, EN21-3101, EN21-3102,EN21-3103, EN21-3104) ndoNest Electrodes (EN12-xxx) (EN21-xx), (EN13-XXX) , (EN12-0001)((EN12002)(EN12-0003)(EN12-0004) EndoNest Drape, EndoNest Urological, EndoNest Disposable Products EndoNest Examination Light, floor Light , Cealing Lights, Single Dom, Double Dome, Mount Light EndoNest Exam Lights (Light IV, 300, 600, 900) and Accessories; EndoNest Examination Light and accessories Led Light Source Portable ,EndoNest Led Portable Light 3-Head LED Examination Lamp; 5-Head LED Examination Lamp; EXAMINATION LAMP; EndoNest Examination Lamp White Light, Floor Light (EN-Sion)(ENS1001)(ENS1002)(ENS1003)(ENS1004)(ENS1005)(ENS1005) EndoNest KIT, EndoNest SURGICAL INSTRUMENT, DISPOSABLE Products EndoNest EndoNest camera, EndoNest surgical and accessories, EndoNest 4k camera , EndoNest 4K Camera Recording Accessories Device Name: XX – 00106, XX – 00107, XX – 00108, XX - 00109; EndoNest mounted along with surgical light Accessories Device Name: XF – 00325 XF – 00326 XF – 00327; Light, Surgical Microsurgical Device Name: ENDOEYE; surgical light; Light, Surgical Surgical, Accessories Device Name: Remote Controller Surgical Lamp accessories Light, Surgical EndoNest Surgical Camera and accessories Intended to be used; Surgical Camera and accessories EndoNest Recorder 4k, 4k googles with camera, EN light, surgical, accessories - Camera, Still Accessories Device Name: Emergency Power Unit (Battery Back-Up) EndoNest Surgical Lamp accessories; Light EndoNest BRUSH, SCRUB(EN0785-SB)(EN0785X), OPERATING-ROOM(EN071001,EN071002,EN071003,EN071004, EndoNest BEDS, EndoNest AC-POWERED ADJUSTABLE HOSPITAL BED , EndoNest Flower Bed, EndoNest Semi Flower Bed EndoNest Electric Table , EndoNest Mannul Table, EndoNest O.t furnitures (EN51-001, EN51-002,EN51-005,EN51-1001) Balfour Retractor, EndoNest All types Retractors (EN21-806)(EN21-807) EndoNest RETRACTOR, EndoNest ALL TYPES (Liver Ratractor, Nathanson Retractor, EndoNest Thomson Retractor EndoNest Snake Retractor,Fan Retractors) (EN801-100), en81-1002,EN21-801,EN21-804,EN21-805) (EN-1005R),(EN1005R)(EN1006R), ENT Easophoscope, EndoNest ENT All Type surgeries EndoNest INSTRUMENT, EndoNest ENT MANUAL SURGICAL , EndoNest Rigid Bronchoscope(EN-100BRO), EndoNestDilator, Urethral Dilator EndoNest EndoNest Disposable Face Shield, EndoNest LED Head Light , EndoNest Ent Light EndoNest ENT Head Light , EndoNest Loops , EndoNest googles ent (EN-1005R),(EN1005R)(EN1006R), ENT Easophoscope, EndoNest ENT All Type surgeries EndoNest INSTRUMENT, EndoNest ENT MANUAL SURGICAL , EndoNest Rigid Bronchoscope(EN-100BRO), EndoNest Accessories, EndoNest Cleaning Brushes, For Endoscope, EndoNest Silicon Oil, EndoNest Washers EndoNest Colposcope (And Colpomicroscope)(EN1006HD, (EN1006)(EN1006UHD) HD Colposcope, Ultra HD Coloposcope, Coloposcope EndoNest LARYNGOSCOPE, EndoNest RIGID, (EN02-001,EN02-003,EN02-004) Endonest sunglasses (non-prescription including photosensitive) Dignostic Labs- (ENC-1001)(ENC-1002)(ENC-1003)(ENC-1004)(ENC-1005)(ENC-1006) EndoNest centrifuges (micro, ultra, refrigerated) for clinical use, Pharma ice / gel packs, ice / gel packs, Endonest orthopedic manual surgical instrument, Endonest Ortho Instruments, Endonest Plaster Instruments Endonest Neuro Instruments Containers , Safepod, Open surgery box , Cidex Tray, Formaline Chamber , Chemical Products Box EndoNest container, EndoNest specimen, sterile Laparoscopy Tray, Laparoscopy Box, Laparoscope Tray,Sinoscopy Tray, EndoNest Pneumatic – Tourniquet (Single chennel EN-17011S), Double ChennelEN-17011D)) EndoNest Touch Model ( (Single chennel EN-17011ST), EndoNest Double ChennelEN-17011DT)) Pneumatic LED Display, EndoNest Pneumatic Touch Display (EN170112) , LOP , PIP EndoNest applicaotrs , EndoNest Instruments for the all surgery INSTRUMENT, CAST REMOVAL, AC-POWERED(All Surgery Instruments) (EN23-100) EndoNest instruments Light, Fiber Optic, EndoNest FOC, EndoNest Lights , EndoNest Cables , EndoNest All Type Cables EndoNest Thullium Laser, Thullium Laser 70W, Thullium Laser 40W , sunbeam 10W EndoNest ENT Laser EndoNest Therapy Laser,(Sunbeam-12w/980nm),(Sunbeam-12w/980nm+10w/1470nm), (Sunbeam-Tripal wavelenght) (Sunbeam Dual Wavelenght)(Subneam -10w1470nm+200mw)(Subneam -12w1470nm+200mw) EndoNest Skin Laser (Subnbeam-SLDL), Diode Laser (sunbeam - 1620D), (Sunbeam-16201),(Sunbeam-16202),(Sunbeam-16302) (Sunbeam Dual Wavelenght)(Subneam -15w1470nm+200mw), Dental Diode Laser (Sunbeam-DDL) EndoNest Diode LAser (Sunbeam-15w/980nm),(Sunbeam-10w/980nm+10w/1470nm), (Sunbeam-Tripal wavelenght) EndoNest WALL VACUUM POWERED(EN03-200,EN03-2001,EN032002,EN032003,EN032004)(EN033001) ndoNest APPARATUS, EndoNest SUCTION, EndoNest OPERATING-ROOM EndoNest Cautery Machine , EndoNest Electrosurgical Cautery Machine, Quickseal, Surgiheal, Fastseal Advance Cautery Machine (EN-2062),(EN-2063)(EN-2064)(EN-2065)(EN-2066)(EN-2067) (ENC-1009)(ENC-1010)(ENC-1011)(ENC-1011) EndoNest refrigerator, EndoNest freezer, EndoNest blood storage, EndoNest vaccine Storage, EndoNest Clinical research organization and research labs (ENC-1007)(ENC-1008) EndoNest LIGHT, SURGICAL, EndoNest FLOOR STANDING EndoNest All in one camera, EndoNest Led Head ligth with camera, EndoNest Fiberoptic Cable EndoNest Single CCD Camera with Recording (EN13-9100),EndoNest Single Chip HD Camera (EN 2008 HD) Endonest Cmos Camera with Recorder , EndoNest HD Camera , EndoNest Hd Camera with recorder ,EndoNest EndoEye Camera EndoNest Three C- Mos Camera (EN16-2020)(EN16-2021)(EN16-2022)(EN16-2023)(EN16-2025)(EN16-2024) EndoNest All Lights unit EndoNest CAMERA, EndoNest SURGICAL AND ACCESSORIES (EN13-9100)(EN13-8200T) , EndoNest Cmos Camera EndoNest Three CCD Camera ,EndoNest High Definition C-MOS Camera with Recording (EN 2017) EndoNest camera Single CCD Camera without Recording (EN16- 2008) EndoNEst EndoEye HD , (EN15-101)(EN15-101R) (EN16-101)(EN16-101-01)(EN16-102-02) EndoNest ICU Bed , (EN51-1001,EN51-1002,EN51-1003) EndoNest BED, EndoNest HYDRAULIC, EndoNest ADJUSTABLE HOSPITAL Pad, Menstrual, Scented, (EN-210)(EN-211 )(EN-212)(EN-213 ) (EN-214)(EN-215 ) (EN-216)(EN-217 ) (EN-218)(EN-219 ) (EN-201 )(EN-202)(EN-203 ) (EN-204)(EN-205 ) (EN-206)(EN-207 ) (EN-208)(EN-209 ) EndoNest Pad, EndoNest Menstrual,EndoNest Unscented, EndoNest Sanitory Pad, EndoNest Sanitory Nepkin (EN-200) EndoNest DIAGNOSTIC, EndoNest Lab equipments , EndoNest Incubator EndoNest DEVICE, EndoNest GENERAL PURPOSE, EndoNest MICROBIOLOGY EndoNest Hook, EndoNest Gastro-Urology, EndoNest Urology Instruments, Working Element, EndoNest Resectoscopy Sheath EN18-1003,EN18-1004, EN18-1005, EN18-1006, EN18-1007,EN18-1008, EN18-2000, EN18-2001 EndoNest Urology Cable, EndoNest Visual Obturator , Loops, Electrode, TURP Set (EN18-1001,EN18-1002, EndoNest Uroflowmeter, EN99-1001,EN99-1002,EN99-1003, Analog /Digital

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMS Bed, Pediatric Open Hospital General Hospital Class 2 880.5140 2025-02-15
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2024-02-14
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2024-02-14
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2025-02-15
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2024-02-14
KMN Chair And Table, Medical General Hospital Class 1 880.6140 2025-02-15
KNN Components, Wheelchair Physical Medicine Class 1 890.3920 2024-02-14
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2024-02-14
HRJ Table, Instrument, Powered, Ophthalmic Ophthalmic Class 1 886.4855 2024-02-14
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2024-02-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-02-14
EZO Urethrotome Gastroenterology, Urology Class 2 876.4770 2024-02-14
HHE Cup, Menstrual Obstetrics/Gynecology Class 2 884.5400 2025-02-15
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2024-02-14
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-02-14
HEC Insufflator, Vaginal Obstetrics/Gynecology Class 1 884.5920 2025-02-15
CAL Laryngoscope, Non-Rigid Anesthesiology Class 1 868.5530 2024-02-14
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2025-02-15
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2024-02-14
EYY Drape, Urological, Disposable General, Plastic Surgery Class 2 878.4370 2025-02-15
KZF Device, Medical Examination, Ac Powered General Hospital Class 1 880.6320 2024-02-14
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2024-02-14
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2025-02-15
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2024-02-14
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2024-02-14
EIG Retractor, All Types Dental Class 1 872.4565 2024-02-14
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2024-02-14
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2025-02-15
FXZ Helmet, Surgical General, Plastic Surgery Class 1 878.4040 2024-02-14
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2024-02-14
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2024-02-14
PTZ Colposcope (And Colpomicroscope), Exempt Obstetrics/Gynecology Class 2 884.1630 2024-02-14
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2024-02-14
HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic Class 1 886.5850 2025-02-15
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2025-02-15
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-02-15
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2025-02-15
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2024-02-14
LGH Instrument, Cast Removal, Ac-Powered Orthopedic Class 1 888.5960 2024-02-14
EAY Light, Fiber Optic, Dental Dental Class 1 872.4620 2024-02-14
NXF Gas, Laser Generating General, Plastic Surgery Class 1 878.4810 2024-02-14
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2024-02-14
NRV Implantable Radio Frequency Transponder System General Hospital Class 2 880.6300 2025-02-15
KSE Refrigerator, Freezer, Blood Storage Hematology Class 2 864.9700 2025-02-15
FSS Light, Surgical, Floor Standing General, Plastic Surgery Class 2 878.4580 2024-02-14
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2024-02-14
FNK Bed, Hydraulic, Adjustable Hospital General Hospital Class 1 880.5110 2024-02-14
HHL Pad, Menstrual, Scented, Scented-Deodorized Obstetrics/Gynecology Class 2 884.5425 2025-02-15
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2024-02-14
LIB Device, General Purpose, Microbiology, Diagnostic Microbiology Class 1 866.2660 2024-02-14
FHB Hook, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2024-02-14
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2025-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

Balwant Rai Business: Tregnostic LLC Email: ceo@thregnostic.com Phone: (302) 6457400

Related Public Records

Same Entity

ENDONEST MEDICAL SYSTEMS LLP
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
K780666 Castle Co. DAYSTAR SELECTRA & SELECTRA/ORBITER 1978-04-27
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28
K851742 Burton Medical Products Corp. MEDICAL EXAMINATION LIGHTS 1985-05-13
K935837 Healthcare Designs AIRHYTHM HEALTHCARE BED 1994-06-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030516433. Last updated year: 2026. Please use registration number 3030516433 when referencing this establishment in official correspondence.
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