Astra Tech Implant System®

A/B-Conical Drill EV-GS 4.2C 8-11-15 mm, Ø3.1/4.2

Registry build 21.09.26
70manufacturers in China registered for this device type
596catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NDP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Ningbo Sezen Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66

Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous

Record

Regulatory record for Astra Tech Implant System®
Listed by Dentsply Implants Manufacturing GmbH, Germany
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2022-07-14
Record revised 2022-09-16 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date
Distribution end date 2026-04-17

Catalogue Numbers

Catalogue numbers for Astra Tech Implant System®
Catalogue number Size Status
25884 In distribution
24627 In distribution
26247 In distribution
22924 In distribution
26059 In distribution
22904 In distribution
25401 In distribution
25412 In distribution
25527 In distribution
22379 In distribution
22911 In distribution
26068 In distribution
22957 In distribution
25863 In distribution
22809 In distribution
26031 In distribution
26216 In distribution
22923 In distribution
25172 In distribution
22198 In distribution
25765 In distribution
26095 In distribution
22906 In distribution
25993 In distribution
25002 In distribution
26062 In distribution
22508 In distribution
24659 In distribution
22124 In distribution
26093 In distribution
25859 In distribution
25644 In distribution
22711 In distribution
26262 In distribution
25655 In distribution
25645 In distribution
25402 In distribution
25985 In distribution
26230 In distribution
24715 In distribution
24927 In distribution
25609 In distribution
25992 In distribution
22910 In distribution
26025 In distribution
25769 In distribution
22462 In distribution
25482 In distribution
25000 In distribution
25544 In distribution
26016 In distribution
24959 In distribution
26037 In distribution
25520 In distribution
25431 In distribution
25987 In distribution
26204 In distribution
26236 In distribution
26032 In distribution
25535 In distribution
22890 In distribution
24795 In distribution
26232 In distribution
24713 In distribution
25011 In distribution
22710 In distribution
26018 In distribution
26237 In distribution
25406 In distribution
22520 In distribution
25885 In distribution
22439 In distribution
25886 In distribution
24999 In distribution
25195 In distribution
25864 In distribution
25396 In distribution
22069 In distribution
26002 In distribution
22465 In distribution
25515 In distribution
26203 In distribution
25524 In distribution
26206 In distribution
25486 In distribution
25855 In distribution
26092 In distribution
22867 In distribution
25784 In distribution
24970 In distribution
26089 In distribution
26050 In distribution
26038 In distribution
22962 In distribution
26077 In distribution
26036 In distribution
22429 In distribution
26234 In distribution
24688 In distribution
24639 In distribution
22876 In distribution
22054 In distribution
24424 In distribution
26060 In distribution
24690 In distribution
25772 In distribution
25728 In distribution
26065 In distribution
22914 In distribution
25773 In distribution
26084 In distribution
22811 In distribution
24173 In distribution
24993 In distribution
24037 In distribution
25523 In distribution
26209 In distribution
25421 In distribution
26260 In distribution
25541 In distribution
24996 In distribution
22884 In distribution
24637 In distribution
25850 In distribution
25168 In distribution
26243 In distribution
26049 In distribution
24199 In distribution
22964 In distribution
24358 In distribution
25423 In distribution
22469 In distribution
25990 In distribution
25607 In distribution
25190 In distribution
25783 In distribution
22814 In distribution
24658 In distribution
25849 In distribution
24716 In distribution
25764 In distribution
24638 In distribution
26091 In distribution
25411 In distribution
22886 In distribution
25199 In distribution
22464 In distribution
24799 In distribution
26210 In distribution
25516 In distribution
26098 In distribution
26194 In distribution
26041 In distribution
26099 In distribution
25519 In distribution
22810 In distribution
25188 In distribution
26235 In distribution
24966 In distribution
25869 In distribution
25540 In distribution
25180 In distribution
26022 In distribution
26057 In distribution
25408 In distribution
24717 In distribution
25537 In distribution
22506 In distribution
22813 In distribution
25721 In distribution
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24718 In distribution
22895 In distribution
26017 In distribution
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22883 In distribution
22688 In distribution
25173 In distribution
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24684 In distribution
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25525 In distribution
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24978 In distribution
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22437 In distribution
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24938 In distribution
25868 In distribution
25851 In distribution
26259 In distribution
26055 In distribution
22916 In distribution
26033 In distribution
26001 In distribution
25001 In distribution
26054 In distribution
22805 In distribution
25856 In distribution
24370 In distribution
25542 In distribution
26215 In distribution
25488 In distribution
24649 In distribution
22908 In distribution
26195 In distribution
24685 In distribution
24722 In distribution
22065 In distribution
22812 In distribution
25424 In distribution
26072 In distribution
26088 In distribution
25853 In distribution
25615 In distribution
22885 In distribution
25978 In distribution
24947 In distribution
26061 In distribution
25163 In distribution
26086 In distribution
26087 In distribution
25606 In distribution
25642 In distribution
26053 In distribution
25467 In distribution
26006 In distribution
25553 In distribution
26208 In distribution
24801 In distribution
26213 In distribution
26047 In distribution
26048 In distribution
26080 In distribution
24957 In distribution
22958 In distribution
26040 In distribution
26085 In distribution
24969 In distribution
22816 In distribution
24021 In distribution
26070 In distribution
26241 In distribution
22432 In distribution
22434 In distribution
22909 In distribution
24720 In distribution
25986 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Accessories, Implant, Dental, Endosseous Southern Implants (PTY) Ltd 1,379
Accessories, Implant, Dental, Endosseous Institut Straumann AG 1,320
Neobiotech Implant System Neobiotech Co., Ltd. 1,112
Inclusive Prismatik Dentalcraft, Inc. 1,045
Medentika Medentika GmbH 1,042
BioHorizons Biohorizons Implant Systems Inc. 1,008
IPD Implant Protesis Dental 2004 SL 998
Klockner Soadco, S.L. 995
Dynamic Abutment Solutions Talladium España, SL 877
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 738
Nobel Biocare® Nobel Biocare AB 703
MIS MIS Implants Technologies Ltd. 615

Showing 12 of 7,548. All products under Accessories, 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