Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029973772

FEI Number

3029973772

Entity Name

PNUAdd Co., Ltd.

City/State/Country

Busan, KR

Establishment Address

145, Geumdan-ro, Geumjeong-gu, 2F, Busan 46241, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PNUAdd Co., Ltd. (Owner Number: 10089089)

Owner / Operator Contact Address

145, Geumdan-ro, Geumjeong-gu, 2F, Busan, KR-26 46241, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PNUADD Standard Surgical KIT_Depth Gaouge, Torque Wrench PNUADD Taper Surgical KIT_ Fixture Driver, Depth Gauge, Torque Ratchet; PNUADD TGK KIT_Lateral Anchor Driver, One Direction Torque Wrench PNUADD Taper Surgical KIT_ Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper Surgical Drill; PNUADD Standard Surgical KIT_Parallel Pin, Fixture Driver, Hex Driver, Drill Stopper; PNUADD TGK KIT_Guide Initial Drill, Guide Step Drill, Guide Taper Drill, Guide Tissue Punch; PNUADD TGK KIT_Drill Guide, Vertical Anchor Screw, Lateral Anchor Screw, Guide Point Drill; PNUADD TGK KIT_Lateral Anchor Drill, Guide Fixture Driver, Mount Driver, Hand Driver; PNUADD Taper Surgical KIT_ Taper Cortical Drill, Parallel Pin, Hand Driver, Ratchet Driver, No Mount Driver; PNUADD Standard Surgical KIT_Lance Drill, Stright Stopper Drill, Final Stopper Drill; ADD POP BOW JB Tray JB Fork Radi+, RAYeTray

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	2025-06-11
KCR	Facebow	Dental	Class 1	872.3220	2023-11-08
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2023-11-06

Official Correspondent

Jong-ho Lee

US Agent Details

Hyunju Kwak Email: Hy-Zook@Hanmail.net Phone: (657) 5569448

Related Public Records

Same Entity

PNUAdd Co., Ltd.

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

View Entity Profile →

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

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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 3029973772. Last updated year: 2026. Please use registration number 3029973772 when referencing this establishment in official correspondence.