Manufacturer registered with FDA
S.G.S. International Ltd
Budapest, Hungary. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 217
- 510(k) clearances
- 22014–2019
- Markets registered in
- 6716 registrations outside the US
- Establishments
- 1Hungary
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name S.G.S. International Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: HungaryOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | S.G.S. International Ltd | 2 clearances | 2014–2019 | Below |
| European Union | EUDAMED | Manufacturer | S.G.S. International Kft | 699 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | S.G.S. INTERNATIONAL Kft.S.G.S. INTERNATIONAL KFT | 12 | 2021–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | S.G.S International Kft. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | S.G.S International kft. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SGS INTERNATIONAL LTD. | 1 | 2016–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What S.G.S. International Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutments Plastic for Casting with Titanium Base & HexAdaptorAnatomic Angular AbutmentAnatomic Angular Abutment for 7PNAnatomic Straight AbutmentAnatomic Straight PEEK AbutmentAngular AbutmentBall AttachmentBall Attachment for P7NCover Screw 73 moreHD Healing Caps with Double ConnectionHealing capHealing Cap for P7NHND Narrow Healing Caps with Double ConnectionHW7D Wide Healing Caps with Double ConnectionHW8D Wide Healing Caps with Double ConnectionHWD Wide Healing Caps with Double ConnectionHWN Wide Healing Cap for P7N implantLong Angular AbutmentNarrow Angular Abutment for 7PNNarrow Healing CapNarrow Healing Cap for P7NNarrow Straight AbutmentNarrow straight Abutment for 7PNOverdenture Attachmentoverdenture CapsP1 Screw type Groovy ImplantP1D Conical Groovy Double Connection ImplantP5D Conical Groovy Double Connection ImplantP7 Conical Groovy ImplantP7D Dental Implant with Double ConnectionP7N Narrow Conical ImplantP7N-3.2, 8mm Narrow Dental Implant 8 mmP7S Integral Groovy ImplantP9S Thin Integral ImplantPEEK ABUTMENTS15D Flat Connection abutmentS16-3.75 The straight one-piece Multi-unit AbutmentS16D-3.75 The straight one-piece Multi-unit AbutmentS17-S7-3.75 17/30 The one-piece angular Multi-unit AbutmentS17D- 17/30 The one-piece angular Multi-unit AbutmentS1AD Anatomic straight abutment with double connectionS1D Straight AbutmentS1ND Narrow Straight abutments with double connectionS1T Abutments for barsS1TD Abutment for Bars w/ Titanium BaseS1TN Abutments for bars w/ Titanium Base (for P7N Implant)S1W/S1WD Straight Wide AbutmentS1W8 Wide Straight 8mm Abutment for D Platform ImplantS1W8D Wide Straight 8mm Abutment for Normal platform internal hexS1WN Straight Wide AbutmentS2AD Anatomic Angular Abutment for D Platform ImplantS2AN Anatomic Angular abutments for P7NS2D Slim Angular abutmentsS2DS Slim Angular abutments for D Platform ImplantS2LD Angular abutments for D Platform ImplantS2N Angular abutment for P7NS3-S7-3.75 17/30 Angular Ball AttachmentS35 S-Lock AbutmentS35-S7-3.75 17/30 S-lock Angular AbutmentS35D S-Lock Abutments for D Platform ImplantS35N S-Lock Abutments for 2.1 Platform Implant for P7N ImplantsS3D Ball AttachmentS4-S7-3.75 17/30 Angular Abutments for immediate loading - overdentureS4D Temporary Abutment for immediate loadingS5-S7-3.75 17/30 Easy-Fix Angular AbutmentS5D Easy-Fix AbutmentS5D-S7D Easy-Fix Angular AbutmentS7-3.75-30 Multi-Base Angular AbutmentS7D- 17/30 Multi-Base Angular AbutmentS8D Smart Lock abutmentsS8D-15 Smart Lock angular abutmentsScrewScrew type AbutmentStraight AbutmentTemporary AbutmentTitanium BaseTitanium sleeveWide Healing CapWide Healing Cap for P7NWide Straight AbutmentWide straight Abutment for 7PN17 Screw type Angular Abutment | 2014 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutments Plastic for Casting with Titanium Base & HexAdaptorAnatomic Angular AbutmentAnatomic Angular Abutment for 7PNAnatomic Straight AbutmentAnatomic Straight PEEK AbutmentAngular AbutmentBall AttachmentBall Attachment for P7NCover Screw 73 moreHD Healing Caps with Double ConnectionHealing capHealing Cap for P7NHND Narrow Healing Caps with Double ConnectionHW7D Wide Healing Caps with Double ConnectionHW8D Wide Healing Caps with Double ConnectionHWD Wide Healing Caps with Double ConnectionHWN Wide Healing Cap for P7N implantLong Angular AbutmentNarrow Angular Abutment for 7PNNarrow Healing CapNarrow Healing Cap for P7NNarrow Straight AbutmentNarrow straight Abutment for 7PNOverdenture Attachmentoverdenture CapsP1 Screw type Groovy ImplantP1D Conical Groovy Double Connection ImplantP5D Conical Groovy Double Connection ImplantP7 Conical Groovy ImplantP7D Dental Implant with Double ConnectionP7N Narrow Conical ImplantP7N-3.2, 8mm Narrow Dental Implant 8 mmP7S Integral Groovy ImplantP9S Thin Integral ImplantPEEK ABUTMENTS15D Flat Connection abutmentS16-3.75 The straight one-piece Multi-unit AbutmentS16D-3.75 The straight one-piece Multi-unit AbutmentS17-S7-3.75 17/30 The one-piece angular Multi-unit AbutmentS17D- 17/30 The one-piece angular Multi-unit AbutmentS1AD Anatomic straight abutment with double connectionS1D Straight AbutmentS1ND Narrow Straight abutments with double connectionS1T Abutments for barsS1TD Abutment for Bars w/ Titanium BaseS1TN Abutments for bars w/ Titanium Base (for P7N Implant)S1W/S1WD Straight Wide AbutmentS1W8 Wide Straight 8mm Abutment for D Platform ImplantS1W8D Wide Straight 8mm Abutment for Normal platform internal hexS1WN Straight Wide AbutmentS2AD Anatomic Angular Abutment for D Platform ImplantS2AN Anatomic Angular abutments for P7NS2D Slim Angular abutmentsS2DS Slim Angular abutments for D Platform ImplantS2LD Angular abutments for D Platform ImplantS2N Angular abutment for P7NS3-S7-3.75 17/30 Angular Ball AttachmentS35 S-Lock AbutmentS35-S7-3.75 17/30 S-lock Angular AbutmentS35D S-Lock Abutments for D Platform ImplantS35N S-Lock Abutments for 2.1 Platform Implant for P7N ImplantsS3D Ball AttachmentS4-S7-3.75 17/30 Angular Abutments for immediate loading - overdentureS4D Temporary Abutment for immediate loadingS5-S7-3.75 17/30 Easy-Fix Angular AbutmentS5D Easy-Fix AbutmentS5D-S7D Easy-Fix Angular AbutmentS7-3.75-30 Multi-Base Angular AbutmentS7D- 17/30 Multi-Base Angular AbutmentS8D Smart Lock abutmentsS8D-15 Smart Lock angular abutmentsScrewScrew type AbutmentStraight AbutmentTemporary AbutmentTitanium BaseTitanium sleeveWide Healing CapWide Healing Cap for P7NWide Straight AbutmentWide straight Abutment for 7PN17 Screw type Angular Abutment | 2014 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Conical DrillConical Drill with StopperConical stopper drillDrill ExtenderDrilling extensionMarker DrillPilot DrillShort DrillSpiral DrillSpiral Drill with Stopper 7 moreStep DrillStopper drillStopper drill boxStraight DrillSurgical kit boxTrephineTrephine Drill | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Adaptor for driverAdaptor KeyAnalogCap KeyClosed Tray TransferDepth checkerDepth gaugeDriver for abutmentDriver for implantEasy-Hand Transfer 15mm for Narrow Platform 24 moreHand DriverHand driver for abutmentHand driver for implantHand tool for S35Hand tool for S8HandleLong hand driver for abutmentParallel PinPlastic transfer for Narrow PlatformProsthetic kit box (instruments)RatchetRatchet HEX Driver for Abutment/ImplantRatchet Triangle KeyRetrieval screwSilicon Retrieving KeySlim TransferTechnician HandleTechnician KeyTechnician ScrewdriverTissue punchTissue Punch DriveTorque RachetTransferTransfer Clips | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| S.G.S. INTERNATIONAL LTDFDA reg. 3011545243 | Budapest, Hungary | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048289). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.