Implantswiss

Bone Level Multi Unit Abutment Lab Analog Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part…

Registry build 21.09.26

Bone Level Multi Unit Abutment Lab Analog Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure.

70manufacturers in China registered for this device type
208catalogue 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 Implantswiss
Listed by Novodent SA, Switzerland
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
510(k) K181266
Record published 2021-04-30
Record revised 2021-05-20 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Special storage condition: Keep away from light and sun
Distribution end date 2021-08-06
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Implantswiss
Catalogue number Size Status
S-TSALA70 In distribution
S-TWSB In distribution
S-BMICTGL In distribution
S-TFDML In distribution
S-BMSAPIC37b In distribution
S-ORADL In distribution
S-POSB In distribution
S-ORG-Ycap In distribution
S-TSALA55 In distribution
S-IBClip-y In distribution
S-BIPGP In distribution
S-BFDML In distribution
S-ORR-A In distribution
S-TICTGCap In distribution
S-12HDML In distribution
S-SAD In distribution
S-TSB In distribution
S-TD4814 In distribution
S-12HDRXL In distribution
S-BLLA In distribution
S-BICP55L In distribution
S-TD5508 In distribution
S-BMICPGPIN In distribution
S-BICPN65L In distribution
S-BFLA In distribution
S-SD2808 In distribution
S-OAPICy In distribution
S-BMFDRL In distribution
S-ICOAPN In distribution
S-12HDRL In distribution
S-TFLA In distribution
S-BICPN45L In distribution
S-TD4810 In distribution
S-TFDMS In distribution
S-ORADS In distribution
S-12HDRXS In distribution
S-BMDLA In distribution
S-TD3710 In distribution
S-MUAPICyN In distribution
S-ND5.5 In distribution
S-ICOAT In distribution
S-OADL In distribution
S-BSALA65 In distribution
S-PD In distribution
S-TD5512 In distribution
S-D/E In distribution
S-BICPN55L In distribution
S-BICP45L In distribution
S-BFDRS In distribution
S-TFDLA In distribution
S-OATICY In distribution
S-TD4812 In distribution
S-BMICPN37L In distribution
S-TICP In distribution
S-BMFDLA In distribution
S-ORG-Gcap In distribution
S-OADS In distribution
S-OATICYN In distribution
S-BMICPGS In distribution
S-PSB In distribution
S-BMIA In distribution
S-TD5510 In distribution
S-BMICPN37S In distribution
S-OALA In distribution
S-BICPGS In distribution
S-TICT In distribution
S-TSAPICb In distribution
S-ICOATG10 In distribution
S-ICOAPG15 In distribution
S-BMUAICP In distribution
S-TD4808 In distribution
S-OIA In distribution
S-TFIC In distribution
S-BMICTN37L In distribution
S-BICTGCap In distribution
S-BICP45S In distribution
S-TSALA40 In distribution
S-TD3714 In distribution
S-TD3712 In distribution
S-TFLLA In distribution
S-BICP65S In distribution
S-DP4.3 In distribution
S-BFDRL In distribution
S-T-RATCHET In distribution
S-LRI In distribution
S-BMSALA37 In distribution
S-BSALA45 In distribution
S-TICPGL In distribution
S-SD2214 In distribution
S-SD2814 In distribution
S-ORG-Pcap In distribution
S-ORLA In distribution
S-ND3.7 In distribution
S-PP2.2 In distribution
S-BMUALA In distribution
S-TFDRS In distribution
S-TD4312 In distribution
S-BODLA In distribution
S-OAPICyN In distribution
S-TFDRL In distribution
S-BSALA55 In distribution
S-BMICPGL In distribution
S-BMICP37S In distribution
S-IB In distribution
S-BSAPIC45b In distribution
S-LTMI In distribution
S-SD2812 In distribution
S-TSALLA40 In distribution
S-IBH In distribution
S-LICAP In distribution
S-TD4314 In distribution
S-BFDMS In distribution
S-BTPK In distribution
S-BMICP37L In distribution
S-MUATICyN In distribution
S-BMFLA In distribution
S-OAHCap In distribution
S-PMUSB In distribution
S-TD4310 In distribution
S-TICPN In distribution
S-TICTG14 In distribution
S-ND3.3 In distribution
S-LAD In distribution
S-BICPN65S In distribution
S-BICPN45S In distribution
S-MUAHCap In distribution
S-TICPW In distribution
S-TLLA In distribution
S-TSALLA55 In distribution
S-IBClip-p In distribution
S-LMht In distribution
S-DP3.7 In distribution
S-BSAPIC55b In distribution
S-ND4.8 In distribution
S-PMSB In distribution
S-ORR In distribution
S-BMFDML In distribution
S-BMICTGCap In distribution
S-BMICT37S In distribution
S-BMICTN37S In distribution
S-BICPN55S In distribution
S-ORRo In distribution
S-BICP55S In distribution
S-TD3708 In distribution
S-TSALLA70 In distribution
S-BSAPIC65b In distribution
S-BMUAICPGPin In distribution
S-BIP45 In distribution
S-BFDLA In distribution
S-ICOATN In distribution
S-IBP In distribution
S-ICOAP In distribution
S-SD2810 In distribution
S-SD2210 In distribution
S-ND4.3 In distribution
S-BMLLA In distribution
S-PLD In distribution
S-TICPGS In distribution
S-SD2212 In distribution
S-IBClip-r In distribution
S-BTSK In distribution
S-TWFDLA In distribution
S-BMICT37L In distribution
S-TICTN In distribution
S-BICP65L In distribution
S-BICPGL In distribution
S-12HDMS In distribution
S-12HDRS In distribution
S-ORRc In distribution
S-TD4308 In distribution
S-BMICTGS In distribution
S-BMFDMS In distribution
S-BMFDRS In distribution
S-BICT65S Withdrawn
S-BICT65L Withdrawn
S-TSAPoCy Withdrawn
S-BICT45S Withdrawn
S-BICT55L Withdrawn
S-BICT45L Withdrawn
S-DP4.3 Withdrawn
S-BICTN65L Withdrawn
S-BICT55S Withdrawn
S-TShA Withdrawn
S-BMUAICPGPin Withdrawn
S-BICTN55S Withdrawn
S-BMSAICap37 Withdrawn
S-LPS Withdrawn
S-TShAPin Withdrawn
S-TOAPICy Withdrawn
S-TOAPICyN Withdrawn
S-DP3.7 Withdrawn
S-BSAICap65 Withdrawn
S-BSAICap55 Withdrawn
S-BSAPIC65c Withdrawn
S-BICTN45L Withdrawn
S-SD2208 Withdrawn
S-BSAICap45 Withdrawn
S-BICTGS Withdrawn
S-BSAPIC55c Withdrawn
S-BSAPIC45c Withdrawn
S-TSAICap Withdrawn
S-BIPGP Withdrawn
S-BICTN55L Withdrawn
S-BICTN65S Withdrawn
S-BICTGL Withdrawn
S-BICTN45S Withdrawn
S-BMSAPIC37c Withdrawn
S-TSAPICc Withdrawn

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