Zirlux

Zirlux Bite Verification Cylinder, Non-Engaging, compatible with: Straumann Tissue Level WN synOcta

Registry build 21.09.26
70manufacturers in China registered for this device type
216catalogue 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 Zirlux
Listed by Henry Schein, Inc., United States
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Premarket notification Exempt
Record published 2018-09-24
Record revised 2018-12-07 (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, manufacturing date
Sizes Height 4.5 to 17.5 mm; outer diameter 4.8 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Zirlux
Catalogue number Size Per pack Status
9010328 In distribution
9010539 In distribution
9010827 Post Height, 13mm 3 In distribution
9010820 Post Height, 13mm 3 In distribution
9010729 Height 16 mm 5 In distribution
9010330 5 In distribution
9010287 Height 11 mm 5 In distribution
9010392 In distribution
9010724 Height 11 mm 5 In distribution
9011372 Post Height, 13mm 3 In distribution
9010834 Post Height, 13mm 3 In distribution
9010396 In distribution
9011376 Post Height, 13mm 3 In distribution
9010648 In distribution
9010599 Post Height, 5.5 mm 5 In distribution
9010398 In distribution
9010819 Post Height, 13mm 3 In distribution
9010936 Height 11 mm 5 In distribution
9010603 In distribution
9010733 Height 17.5 mm 5 In distribution
9010358 In distribution
9010675 In distribution
9010723 Height 11 mm 5 In distribution
9010925 In distribution
9010356 Height 11 mm 5 In distribution
9010842 Post Height, 13mm 3 In distribution
9010727 Height 17.3 mm 5 In distribution
9010321 In distribution
9010506 Height 11 mm 5 In distribution
9010592 Height 11 mm 5 In distribution
9010594 Post Height, 4 mm 5 In distribution
9010744 In distribution
9010291 In distribution
9011395 Post Height, 13mm 3 In distribution
9010352 Height 11 mm 5 In distribution
9010927 In distribution
9011362 Post Height, 13mm 3 In distribution
9010699 In distribution
9010800 In distribution
9010898 Post Height, 13mm 3 In distribution
9010324 In distribution
9010293 In distribution
9010510 In distribution
9010590 Height 11 mm 5 In distribution
9012256 In distribution
9010809 Height 11 mm In distribution
9010329 5 In distribution
9010697 In distribution
9010353 Height 11 mm 5 In distribution
9010824 Post Height, 13mm 3 In distribution
9010394 In distribution
9010937 Height 11 mm 5 In distribution
9010610 In distribution
9010779 In distribution
9010940 Height 11 mm 5 In distribution
9011392 Post Height, 13mm 3 In distribution
9010596 Post Height, 4 mm 5 In distribution
9010928 In distribution
9010535 Height 11 mm 5 In distribution
9010828 Post Height, 13mm 3 In distribution
9010401 In distribution
9010563 In distribution
9010843 Post Height, 13mm 3 In distribution
9010673 Height 11 mm 5 In distribution
9011393 Post Height, 13mm 3 In distribution
9011383 Post Height, 13mm 3 In distribution
9010802 Outer Diameter 4.8 mm In distribution
9010360 In distribution
9011396 Post Height, 13mm 3 In distribution
9010939 Height 11 mm 5 In distribution
9010595 Post Height, 4 mm 5 In distribution
9010540 In distribution
9010830 Post Height, 13mm 3 In distribution
9011370 Post Height, 13mm 3 In distribution
9010363 In distribution
9012252 Post Height, 10mm In distribution
9010776 In distribution
9010775 In distribution
9010934 5 In distribution
9010935 5 In distribution
9010780 5 In distribution
9010289 In distribution
9010840 Post Height, 13mm 3 In distribution
9010999 In distribution
9010933 In distribution
9010954 Height 4.5 mm In distribution
9010725 Height 14.3 mm 5 In distribution
9011373 Post Height, 13mm 3 In distribution
9010362 In distribution
9010605 In distribution
9011379 Post Height, 13mm 3 In distribution
9010701 5 In distribution
9010589 Height 11 mm 5 In distribution
9011371 Post Height, 13mm 3 In distribution
9011011 In distribution
9010537 In distribution
9010837 Post Height, 13mm 3 In distribution
9010778 In distribution
9010825 Post Height, 13mm 3 In distribution
9010286 Height 11 mm 5 In distribution
9010838 Post Height, 13mm 3 In distribution
9010726 Height 15.8 mm 5 In distribution
9011374 Post Height, 13mm 3 In distribution
9010645 In distribution
9012247 Post Height, 10mm In distribution
9010679 In distribution
9010649 In distribution
9010773 In distribution
9010748 In distribution
9012260 In distribution
9010832 Post Height, 13mm 3 In distribution
9010323 In distribution
9010924 In distribution
9010519 5 In distribution
9010811 Height 11 mm In distribution
9010704 5 In distribution
9010597 Post Height, 4 mm 5 In distribution
9010929 In distribution
9011363 Post Height, 13mm 3 In distribution
9010395 In distribution
9011368 Post Height, 13mm 3 In distribution
9010930 In distribution
9011369 Post Height, 13mm 3 In distribution
9011384 Post Height, 13mm 3 In distribution
9010646 In distribution
9010808 Height 8 mm In distribution
9010812 Height 13.2 mm In distribution
9011377 Post Height, 13mm 3 In distribution
9010700 In distribution
9010354 Height 11 mm 5 In distribution
9010516 5 In distribution
9010518 5 In distribution
9010821 Post Height, 13mm 3 In distribution
9010698 In distribution
9010602 Post Height, 5.5 mm 5 In distribution
9010839 Post Height, 13mm 3 In distribution
9010931 In distribution
9010560 In distribution
9010818 Post Height, 13mm 3 In distribution
9010822 Post Height, 13mm 3 In distribution
9010833 Post Height, 13mm 3 In distribution
9011009 In distribution
9010606 In distribution
9011013 In distribution
9011365 Post Height, 13mm 3 In distribution
9011366 Post Height, 13mm 3 In distribution
9010357 In distribution
9010285 Height 11 mm 5 In distribution
9010677 In distribution
9010810 Height 12 mm In distribution
9010562 In distribution
9011367 Post Height, 13mm 3 In distribution
9010598 Post Height, 5.5 mm 5 In distribution
9010651 5 In distribution
9011364 Post Height, 13mm 3 In distribution
9010774 In distribution
9010359 In distribution
9010745 In distribution
9010564 In distribution
9010836 Post Height, 13mm 3 In distribution
9010541 In distribution
9010650 5 In distribution
9010608 In distribution
9010361 In distribution
9010922 In distribution
9010831 Post Height, 13mm 3 In distribution
9010604 In distribution
9010739 Height 11 mm 5 In distribution
9010400 In distribution
9011397 Post Height, 13mm 3 In distribution
9010591 Height 11 mm 5 In distribution
9010813 In distribution
9010611 In distribution
9010741 In distribution
9010736 Height 11 mm 5 In distribution
9010508 In distribution
9010826 Post Height, 13mm 3 In distribution
9011456 Post Height, 13mm 3 In distribution
9012258 In distribution
9010674 Height 11 mm 5 In distribution
9010288 In distribution
9010678 In distribution
9012250 Post Height, 10mm In distribution
9010846 Post Height, 13mm 3 In distribution
9010325 In distribution
9010641 In distribution
9010803 Outer Diameter 4.8 mm In distribution
9010514 In distribution
9010536 Height 11 mm 5 In distribution
9010292 In distribution
9010515 In distribution
9010938 Height 11 mm 5 In distribution
9010327 In distribution
9011375 Post Height, 13mm 3 In distribution
9011003 In distribution
9010722 Height 11 mm 5 In distribution
9010642 In distribution
9010364 In distribution
9010607 In distribution
9010740 Height 11 mm 5 In distribution
9012255 In distribution
9012251 Post Height, 10mm In distribution
9010829 Post Height, 13mm 3 In distribution
9010923 In distribution
9011385 Post Height, 13mm 3 In distribution
9010600 Post Height, 5.5 mm 5 In distribution
9010332 5 In distribution
9010397 In distribution
9011378 Post Height, 13mm 3 In distribution
9010747 In distribution
9010841 Post Height, 13mm 3 In distribution
9010399 In distribution
9010640 In distribution
9010743 In distribution
9010644 In distribution
9010844 Post Height, 13mm 3 In distribution

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