Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011117802

FEI Number

3011117802

Entity Name

VERSAH LLC

City/State/Country

Jackson, MI, US

Establishment Address

2000 Spring Arbor Road, Suite D, Jackson, MI 49203, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VERSAH LLC (Owner Number: 10046965)

Owner / Operator Contact Address

2000 Spring Arbor Road, Suite D, Jackson, MI 49203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Densah Burs Parallel Pin and Parallel Pin XL C-Guides Sleeves Short Tapered Pilot Drill Zygoma Densah Burs G-Stop Keys Zygoma C-Guide Sleeves Zygoma Tapered Drill G-Stop Vertical Gauges Zygoma Guided Keys Tapered Pilot Drill Short Densah Burs Tapered Pilot Drill Densah Burs G-Stop Vertical Gauges G-Stop Keys Short Tapered Pilot Drill Zygoma Densah Burs Short Densah Burs Zygoma Guided Keys C-Guides Sleeves Zygoma C-Guide Sleeve Zygoma Tapered Drill

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	2014-06-05
EJL	Bur, Dental	Dental	Class 1	872.3240	2017-04-20

Official Correspondent

Salah Huwais

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VERSAH LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017835246	VERSAH, LLC	Jackson, MI, US

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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3009847764	GMI DENTAL IMPLANTOLOGY, S.L.	Lleida Lerida, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011117802. Last updated year: 2026. Please use registration number 3011117802 when referencing this establishment in official correspondence.