Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001110146

FEI Number

3001110146

Entity Name

Theia Holding SA

City/State/Country

La Chaux-de-Fonds Neuchatel, CH

Establishment Address

Jardiniere 153, La Chaux-de-Fonds Neuchatel 2300, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Theia Holding SA (Owner Number: 10038408)

Owner / Operator Contact Address

Jardiniere 153, La Chaux-de-Fonds, CH-NE 2300, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IMPLANT BUDDY HADER ATTACHMENTS OEM component, Overmolded Needle Array, for use in IB-Stim non-implanted nerve stimulator LUCKY Torque Wrench OMEGA Torque Wrench

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	2011-10-12
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2011-10-12
QHH	Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)	Gastroenterology, Urology	Class 2	876.5340	2021-06-14
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2014-12-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2011-10-12
HXC	Wrench	Orthopedic	Class 1	888.4540	2011-10-12

Official Correspondent

Adrian Banderet

US Agent Details

Heather Gontz Email: hgontz@younginnovations.com Phone: (800) 2327732

Related Public Records

Same Entity

Theia Holding SA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3026401444	HADER Solutions & Distribution Ltd	Swords CO Dublin, IE

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 3001110146. Last updated year: 2026. Please use registration number 3001110146 when referencing this establishment in official correspondence.