S-Clean TiN Half Coating Angled Abutment S-Line Mini

Dental Implant System / s-Clean TiN Half Coating Angled Abutment s-Line Mini (DSAMZ551537HTS)

Registry build 21.09.26
15manufacturers in China registered for this device type
72catalogue numbers in this listing
13510(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 s-Clean TiN Half Coating Angled Abutment s-Line Mini
Listed by Dentis Co., Ltd., South Korea
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Manufacturer, Exporter
510(k) K210080
Record published 2022-06-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for s-Clean TiN Half Coating Angled Abutment s-Line Mini
Catalogue number Size Status
DSAMZ551537HTS In distribution
DSAMZ451537HTS In distribution
DSAMZ552547FT In distribution
DSAMZ401537FT In distribution
DSAMZ551547FT In distribution
DSAMZ401537HTS In distribution
DSAMZ402537HT In distribution
DSAMZ402547NT In distribution
DSAMZ402547NTS In distribution
DSAMZ402537FT In distribution
DSAMZ552537NTS In distribution
DSAMZ552537HT In distribution
DSAMZ552537FTS In distribution
DSAMZ452537HT In distribution
DSAMZ402547HTS In distribution
DSAMZ451537NTS In distribution
DSAMZ452547HT In distribution
DSAMZ401547NTS In distribution
DSAMZ451547HT In distribution
DSAMZ402537FTS In distribution
DSAMZ401547NT In distribution
DSAMZ452537NT In distribution
DSAMZ552537FT In distribution
DSAMZ451547HTS In distribution
DSAMZ552537HTS In distribution
DSAMZ551547FTS In distribution
DSAMZ401547HTS In distribution
DSAMZ552547HTS In distribution
DSAMZ451537NT In distribution
DSAMZ452547FTS In distribution
DSAMZ552547FTS In distribution
DSAMZ451537FT In distribution
DSAMZ551547NTS In distribution
DSAMZ452537FT In distribution
DSAMZ551547HTS In distribution
DSAMZ551537FT In distribution
DSAMZ452537NTS In distribution
DSAMZ551547NT In distribution
DSAMZ552547NTS In distribution
DSAMZ402537NTS In distribution
DSAMZ452547NTS In distribution
DSAMZ401547HT In distribution
DSAMZ402537NT In distribution
DSAMZ551547HT In distribution
DSAMZ551537HT In distribution
DSAMZ402547FTS In distribution
DSAMZ402547HT In distribution
DSAMZ451547FTS In distribution
DSAMZ451537FTS In distribution
DSAMZ551537NT In distribution
DSAMZ452537FTS In distribution
DSAMZ401537FTS In distribution
DSAMZ552547NT In distribution
DSAMZ552537NT In distribution
DSAMZ451547NTS In distribution
DSAMZ401537NTS In distribution
DSAMZ401537HT In distribution
DSAMZ452537HTS In distribution
DSAMZ402547FT In distribution
DSAMZ451547FT In distribution
DSAMZ401547FT In distribution
DSAMZ452547FT In distribution
DSAMZ552547HT In distribution
DSAMZ551537NTS In distribution
DSAMZ452547HTS In distribution
DSAMZ401547FTS In distribution
DSAMZ451537HT In distribution
DSAMZ401537NT In distribution
DSAMZ451547NT In distribution
DSAMZ452547NT In distribution
DSAMZ402537HTS In distribution
DSAMZ551537FTS 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
K241063 2024-07-25
K230126 2023-08-04
K230307 2023-07-11
K230246 2023-05-25
K230523 2023-05-24
K230203 2023-05-03
K222451 2023-02-07
K222913 2023-01-13
K222976 2023-01-12
K220440 2022-06-16
K210410 2021-09-10
K210362 2021-08-19
K171694 2017-11-29

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