PhysioStar NFC Plus 6er

40 catalogue numbers from 661085, listed by Candulor, AG, Switzerland, under Denture, Plastic, Teeth. 26 manufacturers in China are registered for this product code.

Registry build 21.09.26
26manufacturers in China registered for this device type
40catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (3), Hong Kong (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ELM
Manufacturer City Province Registered as Device types
Shenzhen Jiahong Dental Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Fuzhou Delphin BIO-Tech Co., Ltd. Fuzhou Fujian Manufacturer 18
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Shenzhen Sunmc Dental Technology Co., Ltd. Shenzhen Guangdong Manufacturer 17
Improve Co., Limited Lantau Island Hong Kong Contract manufacturer 16
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Heyuan HEY White Technology Co., Ltd. Heyuan Guangdong Manufacturer 12
Beijing Yingguan Dental Science&Technology Co., Ltd. Beijing Beijing Manufacturer 11
Smile Dental Laboratory Company Limited Zhuhai Guangdong Manufacturer 11

Showing 12 of 26. All 26 manufacturers in China registered for Denture, Plastic, Teeth

Record

Regulatory record for PhysioStar NFC plus 6er
Listed by Candulor, AG, Switzerland
FDA product code ELM
Device type Denture, Plastic, Teeth
Device class Class 2
Regulation 21 CFR 872.3590
Establishment Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer
Record published 2016-10-06
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for PhysioStar NFC plus 6er
Catalogue number Size Status
661085 In distribution
661098 In distribution
661386 In distribution
661356 In distribution
661218 In distribution
661339 In distribution
661036 In distribution
661320 In distribution
661178 In distribution
661027 In distribution
661390 In distribution
661040 In distribution
661481 In distribution
661241 In distribution
661069 In distribution
661148 In distribution
661349 In distribution
661300 In distribution
661475 In distribution
661430 In distribution
661360 In distribution
661392 In distribution
661335 In distribution
661279 In distribution
661182 In distribution
661318 In distribution
661006 In distribution
661192 In distribution
661267 In distribution
661092 In distribution
661304 In distribution
661278 In distribution
661225 In distribution
661112 In distribution
661261 In distribution
661202 In distribution
661453 In distribution
661089 In distribution
661236 In distribution
661347 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Resin Teeth DCL PE Ivoclar Vivadent Aktiengesellschaft 8,657
Primodent Polident d.o.o. 3,814
Resin Teeth S PE S DCL Ivoclar Vivadent Aktiengesellschaft 2,870
Vitapan Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft 2,480
Myerson Special The Myerson Company Limited 2,386
Kenson The Myerson Company Limited 2,365
Candulor TCR Candulor, AG 1,944
Vita Physiodens Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft 1,788
Portrait® IPN® Anteriors Dentsply LLC 1,674
Enigma Denture Teeth – Pairs Davis Schottlander & Davis, Ltd. 1,632
Ivostar Gnathostar Ivoclar Vivadent Aktiengesellschaft 1,501
REF-Line Polident d.o.o. 1,458

Showing 12 of 9,979. All products under Denture, Plastic, Teeth

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