Tools

Ratchet Hex Driver for Abutment, 1.25 mm Diameter, 15 mm length

Registry build 21.09.26
15manufacturers in China registered for this device type
55catalogue numbers in this listing

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 Tools
Listed by A.B. Dental Devices Ltd, Israel
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Specification developer, Manufacturer
510(k) K132125
Record published 2019-10-14
Record revised 2019-11-27 (version 3)

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, expiry date, manufacturing date, serial number
Packaging Bag of 10, bag of 100

Catalogue Numbers

Catalogue numbers for Tools
Catalogue number Size Status
TDL-2.8 In distribution
TDCSt-3.3,10 In distribution
TDL-4.2 In distribution
TDCSt-5.5,13 In distribution
TP-2,31 In distribution
TDCSt-5.5,11.5 In distribution
TDCSt-4.5,6 In distribution
T18-3,18 In distribution
T1-1.2,9 In distribution
TD-2.8 In distribution
T3-I6B-L In distribution
T18-3.75,18 In distribution
TDCSt-4.5,8 In distribution
T3-I6B-S In distribution
TD-3.2 In distribution
TPD-2 In distribution
T18-3,9 In distribution
T3-I6B-18 In distribution
TD-4.5 In distribution
T16 In distribution
T8 In distribution
TDCSt-2.2,13 In distribution
TDCSt-5.5,6 In distribution
T1-1.2,15 In distribution
T2-1.2,9 In distribution
D1-I6b In distribution
P55b-3 In distribution
TD-5 In distribution
TDCSt-4.5,10 In distribution
T3-2,18 In distribution
D2al-3.75 In distribution
T5-2.4,20 In distribution
D2al-3 In distribution
TDL-2.5 In distribution
TDCSt-2.2,11.5 In distribution
TD-2.5 In distribution
TD-4 In distribution
TDCSt-2.2,10 In distribution
TDCSt-5.5,8 In distribution
TD-3.65 In distribution
T3-2.4,9 In distribution
TDCSt-4.5,13 In distribution
TDCSt-4.5,11.5 In distribution
T18-3.75,9 In distribution
PK-D2-3.75 In distribution
TDL-3.2 In distribution
TMD-1.9 In distribution
TDCSt-5.5,10 In distribution
TP-23 In distribution
T3-2.4,18 In distribution
TDCSt-2.2,6 In distribution
D1-I6 In distribution
TDL-3.65 In distribution
T5-2.4,25 In distribution
T2-1.2,15 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

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