Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011545243

FEI Number

3011545243

Entity Name

S.G.S. INTERNATIONAL LTD

City/State/Country

Budapest, HU

Establishment Address

Karolyi Istvan utca 1-3, Budapest H-1047, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

S.G.S. International Ltd (Owner Number: 10048289)

Owner / Operator Contact Address

Karolyi Istvan utca 1-3, Budapest, HU-BU H-1047, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133362

PMA Number

N/A

All Registered Proprietary Names

Transfer Clips Ratchet Ratchet Triangle Key Technician Key Depth gauge Slim Transfer Parallel Pin Adaptor Key Analog Easy-Hand Transfer 15mm for Narrow Platform Silicon Retrieving Key Cap Key Hand Driver Technician Handle Technician Screwdriver Transfer Closed Tray Transfer Tissue Punch Drive Plastic transfer for Narrow Platform Ratchet HEX Driver for Abutment/Implant Prosthetic kit box (instruments) Retrieval screw Adaptor for driver Hand driver for abutment Long hand driver for abutment Driver for abutment Torque Rachet Depth checker Driver for implant Hand tool for S8 Tissue punch Hand driver for implant Hand tool for S35 Handle P7N-3.2, 8mm Narrow Dental Implant 8 mm S1W/S1WD Straight Wide Abutment P1D Conical Groovy Double Connection Implant S1D Straight Abutment S3D Ball Attachment HD Healing Caps with Double Connection S1W8 Wide Straight 8mm Abutment for D Platform Implant S1T Abutments for bars S17-S7-3.75 17/30 The one-piece angular Multi-unit Abutment S35 S-Lock Abutment S35N S-Lock Abutments for 2.1 Platform Implant for P7N Implants S1TD Abutment for Bars w/ Titanium Base S2D Slim Angular abutments S2DS Slim Angular abutments for D Platform Implant Titanium sleeve HW8D Wide Healing Caps with Double Connection S1TN Abutments for bars w/ Titanium Base (for P7N Implant) S16-3.75 The straight one-piece Multi-unit Abutment S8D-15 Smart Lock angular abutments Healing cap HND Narrow Healing Caps with Double Connection S7D- 17/30 Multi-Base Angular Abutment S2AD Anatomic Angular Abutment for D Platform Implant P5D Conical Groovy Double Connection Implant HW7D Wide Healing Caps with Double Connection Adaptor S7-3.75-30 Multi-Base Angular Abutment S2LD Angular abutments for D Platform Implant S3-S7-3.75 17/30 Angular Ball Attachment S8D Smart Lock abutments S2N Angular abutment for P7N HWN Wide Healing Cap for P7N implant S1ND Narrow Straight abutments with double connection P7D Dental Implant with Double Connection S1AD Anatomic straight abutment with double connection S17D- 17/30 The one-piece angular Multi-unit Abutment S5D-S7D Easy-Fix Angular Abutment S1W8D Wide Straight 8mm Abutment for Normal platform internal hex HWD Wide Healing Caps with Double Connection S4D Temporary Abutment for immediate loading S1WN Straight Wide Abutment S2AN Anatomic Angular abutments for P7N S35D S-Lock Abutments for D Platform Implant S5D Easy-Fix Abutment S35-S7-3.75 17/30 S-lock Angular Abutment S15D Flat Connection abutment overdenture Caps S5-S7-3.75 17/30 Easy-Fix Angular Abutment S4-S7-3.75 17/30 Angular Abutments for immediate loading - overdenture S16D-3.75 The straight one-piece Multi-unit Abutment Angular Abutment Anatomic Angular Abutment Cover Screw Screw Wide straight Abutment for 7PN Narrow Healing Cap Long Angular Abutment Narrow Angular Abutment for 7PN Screw type Abutment P9S Thin Integral Implant Narrow Straight Abutment P1 Screw type Groovy Implant Abutments Plastic for Casting with Titanium Base & Hex Narrow straight Abutment for 7PN Healing Cap PEEK ABUTMENT P7S Integral Groovy Implant Anatomic Straight PEEK Abutment 17 Screw type Angular Abutment Healing Cap for P7N Ball Attachment for P7N Wide Straight Abutment Wide Healing Cap for P7N Overdenture Attachment Anatomic Angular Abutment for 7PN Wide Healing Cap P7N Narrow Conical Implant P7 Conical Groovy Implant Titanium Base Ball Attachment Narrow Healing Cap for P7N Straight Abutment Temporary Abutment Titanium Sleeve Anatomic Straight Abutment

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2014-12-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-12-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-12-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-12-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-12-24

Official Correspondent

No official correspondent registered.

US Agent Details

Daniela Levy Business: Sterling Medical Registration Email: Sterlingmedical2017@gmail.com Phone: (213) 7873026

Related Public Records

Same Entity

S.G.S. International 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-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 3011545243. Last updated year: 2026. Please use registration number 3011545243 when referencing this establishment in official correspondence.