Bluediamond Implant

BLUEDIAMOND Implant System (C2.8) Ø3.3/ L15.0

Registry build 21.09.26
15manufacturers in China registered for this device type
60catalogue numbers in this listing
7510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NHA
Manufacturer City Province Registered as Device types
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Modern Dental Laboratory (DG) Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Exceldent Dental Technology Development Co., Ltd. Zhuhai Guangdong Contract manufacturer 12
DTS Digital Dental LAB Shenzhen Guangdong Contract manufacturer 11
KTJ Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shimmer Computerized Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 10
Zhuhai Crystal Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 9
NEW Perfect Dental LAB Shenzhen Guangdong Contract manufacturer 8
Shenzhen Jiahong Dental Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Jiangsu Trausim Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14
CBD Dental LAB, Inc Shenzhen Guangdong Manufacturer 11

Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous

Record

Regulatory record for Bluediamond Implant
Listed by Megagen Implant Co., Ltd., South Korea
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Repacker / relabeller, Manufacturer, Exporter
510(k) K241972
Record published 2025-05-13
Record revised 2026-06-23 (version 2)

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Bluediamond Implant
Catalogue number Size Status
BDC530502D In distribution
BDC480704 In distribution
BDC480706 In distribution
ARO3315D In distribution
ARO3310 In distribution
BDC480704D In distribution
BDC480506D In distribution
ARO3310D In distribution
BDC480906 In distribution
BDC630502D In distribution
BDC580504D In distribution
ARO3707 In distribution
BDC480702 In distribution
BDC480504D In distribution
BDC580702D In distribution
ARO3710D In distribution
ARO3318 In distribution
ARO3715D In distribution
ARO3307 In distribution
BDC480502D In distribution
BDC480902 In distribution
BDC580704D In distribution
ARO3708 In distribution
BDC480706D In distribution
ARO3713 In distribution
BDC480702D In distribution
BDC580502D In distribution
BDC630704D In distribution
ARO3715 In distribution
ARO3308D In distribution
BDC480902D In distribution
ARO3308 In distribution
ARO3707D In distribution
ARO3708D In distribution
ARO3313D In distribution
ARO3311D In distribution
BDC530704 In distribution
BDC530502 In distribution
BDC480506 In distribution
BDC530504 In distribution
BDC480904D In distribution
BDC630702D In distribution
ARO3318D In distribution
BDC630504D In distribution
ARO3711 In distribution
BDC480502 In distribution
BDC530702D In distribution
BDC530702 In distribution
ARO3315 In distribution
ARO3311 In distribution
ARO3710 In distribution
BDC480504 In distribution
ARO3307D In distribution
BDC480906D In distribution
BDC480904 In distribution
BDC530504D In distribution
ARO3313 In distribution
BDC530704D In distribution
ARO3711D In distribution
ARO3713D In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MEDENTiKA Medentika GmbH 2,553
LW Vis Abutment Ossvis Co., Ltd. 2,520
Dess dental smart solutions Terrats Medical SL 1,715
Locator Zest Anchors, LLC 1,643
NobelProcera® Nobel Biocare AB 1,526
Azure Terrats Medical SL 1,360
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 1,308
LW Vis Abutment SET Ossvis Co., Ltd. 1,260
Abutment, Implant, Dental, Endosseous Southern Implants (PTY) Ltd 1,240
Healing Abutment Megagen Implant Co., Ltd. 1,218
Chaorum Implant System Medimecca Co Ltd 1,084
OT Equator Rhein 83 SRL 1,051

Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K242030 2025-01-13
K234142 2024-09-18
K233450 2024-01-22
K220562 2022-11-10
K210826 2022-02-03
K203808 2021-10-20
K192614 2020-02-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer