ZIMA INTERNATIONAL, INC.

FDA Device Registration & Listing · Lehi, UT, US · Registration 3032802037

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032802037
FEI Number
3032802037
Entity Name
ZIMA INTERNATIONAL, INC.
City/State/Country
Lehi, UT, US
Establishment Address
1320 N 300 W, Lehi, UT 84043, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Zima International, Inc. (Owner Number: 10053996)
Owner / Operator Contact Address
11 Park Place, 3rd Floor - Suite 502, New York, NY 10007, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Medentika CAD/CAM TiBases Dandy Surgical Guide, Abutment Insertion Guide DESS Dental Smart Solutions

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-09-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-07-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-07-18
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2025-07-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-07-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-07-18

Official Correspondent

Daniel Hanover

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zima International, 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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032802037. Last updated year: 2026. Please use registration number 3032802037 when referencing this establishment in official correspondence.
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