Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010251542

FEI Number

3010251542

Entity Name

ZUGA MEDICAL, INC.

City/State/Country

Cleveland, OH, US

Establishment Address

1163 E 40th St Ste 202, Cleveland, OH 44114, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zuga Medical, Inc. (Owner Number: 10044268)

Owner / Operator Contact Address

11545 Ascot Ln, Chagrin Falls, OH 44023, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122664

PMA Number

N/A

All Registered Proprietary Names

Zuga Burs for Zuga Dental Implant Systems Dental Drills for Zuga Dental Implant Systems Zuga

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	2013-05-20
EJL	Bur, Dental	Dental	Class 1	872.3240	2015-08-20
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2015-08-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-05-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-05-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zuga Medical, Inc.

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.

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3017896270	EXCELLENT PRECISION TECHNOLOGY (DONGGUAN) CO., LTD	Dongguan Guangdong, CN
3042200066	HUB BIOTECH CO., LTD.	BUCHEON-SI Gyeonggi, KR
3042852773	COVISION CO., LTD.	Incheon, KR
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 3010251542. Last updated year: 2026. Please use registration number 3010251542 when referencing this establishment in official correspondence.