Safco Gutta Percha Points

Safco guttapercha #45 slide iso 120bx

Registry build 21.09.26
42manufacturers in China registered for this device type
90catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Shanghai (8), Jiangsu (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EKM
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Dentsply Dental (Tianjin) Co., Ltd. Teda Tianjin Contract manufacturer 2
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
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Shanghai Dochem Industries Co., Ltd. Shanghai Shanghai Manufacturer 45

Showing 12 of 42. All 42 manufacturers in China registered for Gutta-Percha

Record

Regulatory record for Safco gutta percha points
Listed by Safco Dental Supply, United States
FDA product code EKM
Device type Gutta-Percha
Device class Class 1
Regulation 21 CFR 872.3850
Premarket notification Exempt
Record published 2021-07-16
Record revised 2022-06-23 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Safco gutta percha points
Catalogue number Size Per pack Status
1024665 120 In distribution
1024811 100 In distribution
1024745 120 In distribution
1024755 120 In distribution
1024901 60 In distribution
1024864 100 In distribution
1024678 120 In distribution
1024970 60 In distribution
1024887 60 In distribution
1024811 100 In distribution
1024969 60 In distribution
1024689 120 In distribution
1024715 120 In distribution
1024692 120 In distribution
1024846 100 In distribution
1024730 120 In distribution
1024887 60 In distribution
1024879 100 In distribution
1024735 120 In distribution
1024833 100 In distribution
1024895 60 In distribution
1024616 120 In distribution
1024647 120 In distribution
1024740 120 In distribution
1024651 120 In distribution
1024603 120 In distribution
1024895 60 In distribution
1024725 120 In distribution
1024852 100 In distribution
1024919 60 In distribution
1024892 60 In distribution
1024647 120 In distribution
1024750 120 In distribution
1024745 120 In distribution
1024926 60 In distribution
1024892 60 In distribution
1024875 100 In distribution
1024947 60 In distribution
1024720 120 In distribution
1024885 60 In distribution
1024934 60 In distribution
1024929 60 In distribution
1024759 120 In distribution
1024852 100 In distribution
1024890 60 In distribution
1024740 120 In distribution
1024755 120 In distribution
1024901 60 In distribution
1024969 60 In distribution
1024624 120 In distribution
1024875 100 In distribution
1024616 120 In distribution
1024947 60 In distribution
1024908 60 In distribution
1024725 120 In distribution
1024632 120 In distribution
1024890 60 In distribution
1024864 100 In distribution
1024665 120 In distribution
1024624 120 In distribution
1024720 120 In distribution
1024730 120 In distribution
1024715 120 In distribution
1024750 120 In distribution
1024913 60 In distribution
1024678 120 In distribution
1024919 60 In distribution
1024651 120 In distribution
1024973 60 In distribution
1024908 60 In distribution
1024934 60 In distribution
1024970 60 In distribution
1024958 60 In distribution
1024833 100 In distribution
1024958 60 In distribution
1024692 120 In distribution
1024689 120 In distribution
1024882 60 In distribution
1024879 100 In distribution
1024973 60 In distribution
1024913 60 In distribution
1024929 60 In distribution
1024926 60 In distribution
1024603 120 In distribution
1024759 120 In distribution
1024632 120 In distribution
1024735 120 In distribution
1024885 60 In distribution
1024882 60 In distribution
1024846 100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Gutta Percha Points Diadent Group Intl., Inc. 1,404
MM Marked Gutta Percha Points Diadent Group Intl., Inc. 683
Henry Schein Henry Schein, Inc. 386
Zarc Shanghai Xing YU Medical Equipment Co., Ltd. 166
Darby Dental Supply, LLC Darby Dental Supply, LLC 130
Brasseler USA Peter Brasseler Holdings, LLC 126
Avalon Biomed Shanghai Xing YU Medical Equipment Co., Ltd. 106
Advance Dental Products THE Atlanta Dental Supply Company 97
Sure-endo Sure Dent Corporation 89
3D Endo 3D Dental Designs AND Development, LLC 82
Endodontic Obturators Tulsa Dental Products LLC 78
Midway Select Midway Dental Supply, LLC 70

Showing 12 of 599. All products under Gutta-Percha

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