Gutta Percha Points

Gutta Percha Points is used to root canal filing material.

Registry build 21.09.26
42manufacturers in China registered for this device type
1,404catalogue 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 Gutta Percha Points
Listed by Diadent Group Intl., Inc., Canada
FDA product code EKM
Device type Gutta-Percha
Device class Class 1
Regulation 21 CFR 872.3850
Establishment Repacker / relabeller, Private-label distributor, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-04-06
Record revised 2020-04-09 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 27 °C; Special storage condition: Keep away from flammable and combustible materials and heat; Special storage condition: Keep Dry and away from Sunlight

Catalogue Numbers

Catalogue numbers for Gutta Percha Points
Catalogue number Size Status
DIA-PROT PLUS F5 In distribution
DIA-35m/m 15 In distribution
.06 TAPER 70 In distribution
FEATHERED TIP M In distribution
VETERINARY POINTS(45mm A) M In distribution
.04 TAPER 50 In distribution
DIA-SYSTEM GTP.08 40 In distribution
DIA-35m/m 130 In distribution
ACCESSORY XF In distribution
DIA-PROISO-.06 90 In distribution
DIA-35m/m ASST 15/25 In distribution
DIA-ISOGT-.04 ASST 45/80 In distribution
ISO 120 In distribution
ACCESSORY FM In distribution
DIA-PROISO-.06 45 In distribution
ISO 30 In distribution
SPILL PROOF ENDO ORGANIZER EG1 EMPTY In distribution
ISO 40 In distribution
ISO 100 In distribution
DIA-35m/m 55 In distribution
BRAZILIAN B1 In distribution
VETERINARY POINTS(60mm) 130 In distribution
DIA-PRO DT.06/.04 25 In distribution
DIA-35m/m ASST 60/80 In distribution
DIA-ISOGT-.08 20 In distribution
DIA-PROISO-.04 25 In distribution
ACCESSORY XL In distribution
FEATHERED TIP M In distribution
ISO 130 In distribution
.06 TAPER 60 In distribution
ISO 90 In distribution
ACCESSORY FM In distribution
.06 TAPER 60 In distribution
FEATHERED TIP FM In distribution
ACCESSORY F In distribution
ISO 25 In distribution
DIA-ISOGT-.08 10 In distribution
ISO 80 In distribution
ISO ASST 45/80 In distribution
DIA-ISOGT-.04 ASST 45/80 In distribution
ISO 80 In distribution
DIA-PINK TYPE DXXF In distribution
ISO 100 In distribution
ISO 25 In distribution
ISO 140 In distribution
ISO 35 In distribution
DIA-ISOGT-.05 80 In distribution
DIA-35m/m 45 In distribution
ISO 100 In distribution
.04 TAPER 45 In distribution
ISO 15 In distribution
ACCESSORY XL In distribution
DIA-SYSTEM GTP.10 35 In distribution
DIA-ISOGT-.04 120 In distribution
VETERINARY POINTS(60mm) 55 In distribution
ISO 30 In distribution
DIA-SYSTEM GTP.10 35 In distribution
ISO 35 In distribution
DIA-SYSTEM GTP.06 25 In distribution
DIA-SYSTEM GTP.06 20 In distribution
ENDO ORGANIZER COMBI 3 15/40 In distribution
DIA-ISOGT-.08 90 In distribution
FEATHERED TIP L In distribution
ISO 130 In distribution
VETERINARY POINTS(45mm B) 35 In distribution
.04 TAPER 45 In distribution
ACCESSORY XF In distribution
.06 TAPER 8 In distribution
DIA-PROISO-.06 70 In distribution
DIA-PROISO-.06 35 In distribution
ACCESSORY MF In distribution
VETERINARY POINTS(60mm) 50 In distribution
.06 TAPER 50 In distribution
ISO 110 In distribution
DIA-GTP 0.12 In distribution
DIA-ISOGT-.08 8 In distribution
DIA-PRO-.06 ASST 2/7 In distribution
ISO 15 In distribution
DIA-PROT PLUS B4 In distribution
FEATHERED TIP M In distribution
.06 TAPER 20 In distribution
ACCESSORY L In distribution
ISO 50 In distribution
ISO ASST 15/40 In distribution
DIA-PINK TYPE ASST DXXF/DL In distribution
DIA-ISOGT-.04 30 In distribution
DIA-ISOGT-.10 30 In distribution
DIA-SYSTEM GTP #20 ASST In distribution
FEATHERED TIP M In distribution
DIA-ISOGT-.08 130 In distribution
ISO 8 In distribution
DIA-PRO-.06 2 In distribution
ISO 30 In distribution
ISO 100 In distribution
VETERINARY POINTS(45mm B) 15 In distribution
DIA-FIT 0.06 In distribution
ISO 10 In distribution
ISO ASST 90/140 In distribution
ISO 35 In distribution
ISO 80 In distribution
DIA-ISOGT-.05 70 In distribution
DIA-35m/m 40 In distribution
ACCESSORY ASST XF/M In distribution
ENDO ORGANIZER EGP6 15/80 In distribution
ACCESSORY FM In distribution
ACCESSORY L In distribution
ISO 15 In distribution
ACCESSORY ASST XF/M In distribution
ISO 140 In distribution
DIA-SYSTEM GTP.04 40 In distribution
ISO 80 In distribution
DIA-ISOGT-.04 110 In distribution
ISO 120 In distribution
ISO 40 In distribution
.06 TAPER 15 In distribution
ACCESSORY XF In distribution
DIA-PINK TYPE DL In distribution
ACCESSORY MF In distribution
ISO ASST 45/80 In distribution
DIA-SYSTEM GTP.06 40 In distribution
DIA-PINK TYPE ASST(XXF,XF,F,F,M,L) In distribution
mm marked 25 In distribution
ISO 25 In distribution
DIA-PROT PLUS F1 In distribution
DIA-ISOGT-.12 20 In distribution
ISO 55 In distribution
ENDO ORGANIZER EGP5 45/80 In distribution
ACCESSORY MF In distribution
ISO 110 In distribution
DIA-ABCD B In distribution
.06 TAPER 80 In distribution
.06 TAPER ASST 15/40 In distribution
DIA-ISOGT-.06 8 In distribution
DIA-ISOGT-.06 30 In distribution
ISO 35 In distribution
DIA-PRO-.06 10 In distribution
ACCESSORY MF In distribution
ISO 30 In distribution
DIA-ISOGT-.05 110 In distribution
ISO 35 In distribution
ISO 55 In distribution
ISO ASST 15/40 In distribution
.06 TAPER 80 In distribution
DIA-35m/m 50 In distribution
DIA-ISOGT-.12 55 In distribution
DIA-ISOGT-.05 45 In distribution
DIA-ISOGT-.04 50 In distribution
ISO 30 In distribution
DIA-35m/m ASST 45/55 In distribution
ISO 100 In distribution
ISO 110 In distribution
ISO 70 In distribution
ISO ASST 90/140 In distribution
ISO 130 In distribution
ISO 40 In distribution
DIA-35m/m 60 In distribution
ISO 90 In distribution
DIA-SYSTEM GTP.04 30 In distribution
ISO 20 In distribution
FEATHERED TIP XL In distribution
ISO 35 In distribution
ISO 40 In distribution
ISO 20 In distribution
ISO 15 In distribution
ISO 25 In distribution
ISO 140 In distribution
ISO ASST(15,20,25,30,40,50) In distribution
.06 TAPER 25 In distribution
DIA-PINK TYPE DXXF In distribution
mm marked 10 In distribution
DIA-ISOGT-.06 45 In distribution
mm marked 8 In distribution
ISO 55 In distribution
FEATHERED TIP L In distribution
ISO 110 In distribution
ISO 140 In distribution
.04 TAPER 20 In distribution
ACCESSORY XL In distribution
DIA-ISOGT-.04 70 In distribution
ISO ASST 45/80 In distribution
ACCESSORY MF In distribution
ACCESSORY MF In distribution
ISO 20 In distribution
DIA-PROISO-.06 ASST 15/40 In distribution
DIA-PINK TYPE DF In distribution
DIA-ISOGT-.06 ASST 45/80 In distribution
FEATHERED TIP XL In distribution
ISO 30 In distribution
ISO 25 In distribution
ISO 30 In distribution
DIA-ISOGT-.06 25 In distribution
.06 TAPER 70 In distribution
DIA-ISOGT-.05 40 In distribution
DIA-35m/m 15 In distribution
DIA-PROISO-.06 20 In distribution
ISO 60 In distribution
DIA-PROT PLUS F3 In distribution
DIA-ISOGT-.10 40 In distribution
ISO 140 In distribution
ACCESSORY MF In distribution
ISO 90 In distribution
.04 TAPER 25 In distribution
DIA-ISOGT-.05 60 In distribution
DIA-ISOGT-.04 10 In distribution
ISO 60 In distribution
.04 TAPER 40 In distribution
.06 TAPER 30 In distribution
VETERINARY POINTS(60mm) 15 In distribution
DIA-ISOGT-.04 120 In distribution
ENDO ORGANIZER mmCOMBI 2 45/80 In distribution
ISO 55 In distribution
VETERINARY POINTS(60mm) ASST 30/40 In distribution
ISO 140 In distribution
.06 TAPER 80 In distribution
ACCESSORY M In distribution
DIA-ISOGT-.12 50 In distribution
ISO ASST 45/80 In distribution
ISO 40 In distribution
DIA-PINK TYPE DL In distribution
ISO 90 In distribution
DIA-PROISO-.06 ASST 45/80 In distribution
ISO 20 In distribution
ISO 70 In distribution
ISO 140 In distribution
ISO 90 In distribution
ISO 55 In distribution
DIA-SYSTEM GTP.08 20 In distribution
ISO 55 In distribution
DIA-PRO-.06 6 In distribution
ACCESSORY ML In distribution
DIA-ISOGT-.04 100 In distribution
ACCESSORY M In distribution
DIA-PROISO-.06 140 In distribution
FEATHERED TIP ASST XF/M In distribution
DIA-ISOGT-.04 25 In distribution
DIA-ISOGT-.04 60 In distribution
DIA-PROISO-.06 50 In distribution
DIA-PINK TYPE DXF In distribution
ISO 110 In distribution
ISO 80 In distribution
ISO 90 In distribution
ACCESSORY F In distribution
DIA-ISOGT-.12 ASST 15/40 In distribution
DIA-ABCD ASST(A.B.C.D) In distribution
DIA-ISOGT-.06 25 In distribution
DIA-PROISO-.06 20 In distribution
ISO 120 In distribution
.06 TAPER 10 In distribution
ISO 100 In distribution
SPILL PROOF ENDO ORGANIZER EGP3 15/80 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Safco gutta percha points Safco Dental Supply 90
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