Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010654657

FEI Number

3010654657

Entity Name

KAISER PRECISION CO.

City/State/Country

Hwaseong Gyeonggi, KR

Establishment Address

34, Dongtansandan 5-gil, Dongtan-myeon, Hwaseong Gyeonggi 18487, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kaiser Precision Co. (Owner Number: 10045809)

Owner / Operator Contact Address

34, Dongtansandan 5-gil, Dongtan-myeon, Hwaseong, KR-41 18487, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lifting Drill Lindemann Drill Round Bur Point Drill Step Drill Zirconia Drill (ZID) Straight Drill Torque Ratchet Drill Extension Trephine Drill Torque Wrench Zirconia Crestal Drill ZIrconia Dome Drill Zirconia Round Bur SINUS DRILL (SSC 25, SSC 30, SSC 33, SSC 42, SSC 45) SINUS LATERAL NUMBER 6 BUR (SLBUR6) SINUS CRESTAL INITIAL DRILL (SCINTDRILL) SINUS LATERAL DRILL (SLDR2065, SLDR2075, SLDR2085, SLDR3565, SLDR3575, SLDR3585) SINUS CRESTAL DRILL (SCDRILL24, SCDRILL28, SCDRILL32, SCDRILL36, SCDRILL44) Zirconia Bone Collector Zirconia Bone Expander SINUS CRESTAL STOPPER (SCSTOPPER02, SCSTOPPER03, SCSTOPPER04, SCSTOPPER05, SCSTOPPER06) SINUS CRESTAL STOPPER (SCSTOPPER07, SCSTOPPER08, SCSTOPPER09, SCSTOPPER10, SCSTOPPER11) IMPLANT REMOVAL RATCHET WRENCH (IRRW) SINUS CRESTAL APPROACH KIT VERSION 2 (SCAKITV2) IMPLANT REMOVER (IR315, IR415, IR515, IR615, IR320, IR420, IR520, IR620) IMPLANT REMOVAL SCREW REPLACEMENT (IRSR14, IRSR16, IRSR18, IRSR172, IRSR20, IRSR25) SINUS CRESTAL INSERTER (SCINSERTER) SINUS CRESTAL KIT CASE (SCACASE) SINUS CRESTAL DEPTH GAUGE (SCDPTHGAUGE) SINUS STOPPER (SDS 040, SDS 050, SDS 060, SDS 070, SDS 080, SDS 090, SDS 100) Dr.Eagles Sinus CASE (ESKCASE) SINUS CRESTAL BONE SYRINGE (SCBONESYR) SINUS CRESTAL BONE CONDENSER (SCBONECNDSR) SINUS COMBO KIT (SCOMKIT) SINUS LATERAL ELEVATOR (SLELV1, SLELV2, SLELV3) SINUS CRESTAL SPREADER (SCSPRDR27, SCSPRDR31, SCSPRDR39) SINUS CRESTAL STOPPER HOLDERS (SCSTPRHLDR) IMPLANT REMOVAL KIT CASE (IRCASE) SINUS DEPTH GAGE (SDG) IMPLANT REMOVAL KIT (IRKIT) SCREW DRIVER (SD7, SD12, SD17) SINUS LATERAL KIT CASE (SLACASE) Dr.Eagles Sinus Kit (ESKC) SINUS LATERAL APPROACH KIT VERSION 3 (SLAKITV3) SINUS STOPPER HOLDER (SDSP)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2013-12-30
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2015-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Grace Kim Business: J.S. CHEM INTERNATIONAL CO. Email: gracejschem@hotmail.com Phone: (310) 5983012

Related Public Records

Same Entity

Kaiser Precision Co.

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010654657. Last updated year: 2026. Please use registration number 3010654657 when referencing this establishment in official correspondence.