Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012465917

FEI Number

3012465917

Entity Name

BIO CONCEPT CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.1019, Liaohe Road, Xinbei District, Changzhou Jiangsu 213000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIO CONCEPT Co., Ltd (Owner Number: 10050525)

Owner / Operator Contact Address

No.1019, Liaohe Road, Xinbei District, Changzhou, CN-JS 213000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Torque Driver NoMount Driver Screw-retained Abutment Digital Analog Guide Screw Multi Angled Abutment Carrier Drill Extender Esthetic-low Lab Analog Esthetic-low Pick-up Impression Coping Impression Post Closed Tray Fixture Driver Scanbody Esthetic-low Transfer Impression Coping SR Tip Machine Screw Driver Torque Extension Slot Driver Drill Extension Esthetic-low Polishing Protector NoMount Torque Driver Mono Scanbody Explantation Device Positioning Cylinder Multi Abutment Outer Driver Anchor Screw Screw Removal Tip Digital Analog Guide Driver Metal Sleeve Octagon Positioning Cylinder Tap Impression Post Screw-retained Abutment Analog Template Fixation Pin Impression Cap Positioning Jig BV Dental Implant System BLT Dental Implant System Dental Implant System BC Removal Kit BLT Guided Kit BV Standard Kit BV Removal Kit TL Mini Kit BV Guided Kit BV Mini Kit BLT Mini Kit BL Mini Kit

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	2024-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-07-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-07-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-08-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-08-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-11-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-11-29
NYE	Fixture Mount Kit	Dental	Class 1	872.3980	2024-09-13

Official Correspondent

No official correspondent registered.

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

BIO CONCEPT Co., Ltd

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012465917. Last updated year: 2026. Please use registration number 3012465917 when referencing this establishment in official correspondence.