Astra Tech Implant System® EV

HealDesign™ Profile EV 4.2 Ø 6.5 - 3 mm Triangular

Registry build 21.09.26
15manufacturers in China registered for this device type
89catalogue 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 Astra Tech Implant System® EV
Listed by Dentsply Implants Manufacturing GmbH, Germany
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Contract manufacturer, Manufacturer
Record published 2017-05-01
Record revised 2023-06-12 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Storage in the original packaging, in a dry place, at normal room temperature.
Distribution end date 2025-10-14

Catalogue Numbers

Catalogue numbers for Astra Tech Implant System® EV
Catalogue number Size Status
26191 In distribution
26129 In distribution
26128 In distribution
25631 In distribution
26179 In distribution
25594 In distribution
25593 In distribution
26182 In distribution
26160 In distribution
26186 In distribution
26177 In distribution
26183 In distribution
26172 In distribution
25633 In distribution
26121 In distribution
26159 In distribution
26178 In distribution
25650 In distribution
26132 In distribution
26165 In distribution
26168 In distribution
25595 In distribution
26163 In distribution
26117 In distribution
26180 In distribution
26122 In distribution
25620 In distribution
26162 In distribution
25628 In distribution
26116 In distribution
25584 In distribution
26115 In distribution
25622 In distribution
25586 In distribution
25757 In distribution
26131 In distribution
26161 In distribution
26187 In distribution
26124 In distribution
25592 In distribution
25587 In distribution
26190 In distribution
26167 In distribution
25591 In distribution
26189 In distribution
25590 In distribution
26181 In distribution
25621 In distribution
26126 In distribution
25625 In distribution
26196 In distribution
26192 In distribution
25598 In distribution
25596 In distribution
26171 In distribution
26164 In distribution
25588 In distribution
25585 In distribution
26169 In distribution
25626 In distribution
25619 In distribution
26125 In distribution
26166 In distribution
26184 In distribution
25589 In distribution
26130 In distribution
25632 In distribution
26174 In distribution
26185 In distribution
25756 In distribution
26170 In distribution
26193 In distribution
25599 In distribution
25634 In distribution
25627 In distribution
26175 In distribution
26123 In distribution
25597 In distribution
26176 In distribution
26202 In distribution
26127 In distribution
26188 In distribution
26173 In distribution
25758 Withdrawn
25759 Withdrawn
25890 Withdrawn
25893 Withdrawn
25892 Withdrawn
25891 Withdrawn

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