Endo@pex

The Lightest and Most Efficient 2-in-1 Cordless Obturation System Endo-Apex is one of the most advanced and efficient cordless obturation system ever introduced. Endo-Apex successfully…

Registry build 21.09.26

The Lightest and Most Efficient 2-in-1 Cordless Obturation System Endo-Apex is one of the most advanced and efficient cordless obturation system ever introduced. Endo-Apex successfully delivers predictable results in vertical condensation and 3 dimensional thermo-plasticized obturation. The 2 most effective individual obturation device (Friendo, Gutta Easy) are beautifully combined as one convenient package for maximum efficiency

19manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EKR
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Shanghai Smedent Medical Instrument Co., Ltd. Shanghai Shanghai Repacker / relabeller 30
CDM Center OF Excellence Ltd. Beijing Beijing Manufacturer 29
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15

Showing 12 of 19. All 19 manufacturers in China registered for Plugger, Root Canal, Endodontic

Record

Regulatory record for Endo@pex
Listed by DXM Co., Ltd., South Korea
FDA product code EKR
Device type Plugger, Root Canal, Endodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2023-06-19

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries serial number
Storage Handling environment atmospheric pressure 60 to 106 KiloPascal; Handling environment humidity 10 to 85 % RH; Handling environment temperature 10 to 40 °C

Catalogue Numbers

Catalogue numbers for Endo@pex
Catalogue number Size Status
Endo@pex In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HU-Friedy HU-Friedy MFG Co., LLC 268
Brasseler USA Peter Brasseler Holdings, LLC 93
Power Dental USA Power Dental U.S.A. Inc. 82
Integra® Miltex® Integra LifeSciences Production Corporation 69
Needle B&L Biotech Co., Inc. 40
American Eagle Instruments American Eagle Instruments 33
Henry Schein Henry Schein, Inc. 33
Premier Pluggers Premier Dental Products Co. 29
EQ-V Meta Systems Co., Ltd. 26
Obtura Spartan Young Innovations Inc. 25
Darby Dental Supply, LLC Darby Dental Supply, LLC 22
Nordent Manufacturing Inc Nordent Manufacturing Inc 22

Showing 12 of 136. All products under Plugger, Root Canal, Endodontic

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