Splint Grid Nylon Mesh Roll

Splint Grid Nylon Mesh 39" Roll

Registry build 21.09.26
4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Hebei (1), Hunan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EBL
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Cangzhou Lankang Medical Instruments Developing Co., Ltd. Cangzhou Hebei Manufacturer 40
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for Splint Grid Nylon Mesh Roll
Listed by Cynosure, LLC, United States
FDA product code EBL
Device type Pin, Retentive And Splinting, And Accessory Instruments
Device class Class 1
Regulation 21 CFR 872.3740
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2016-09-21
Record revised 2024-10-21 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Splint Grid Nylon Mesh Roll
Catalogue number Size Status
ESG118 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Blue Sky Bio, LLC Blue SKY BIO, LLC 571
Edenta Edenta Etablissement 155
TMS Coltene/Whaledent Gmbh & Co. KG 46
Code Rings Pulpdent Corporation 31
Brasseler USA Peter Brasseler Holdings, LLC 19
rematitan® Dentaurum GmbH & Co. KG 16
Stabilok Fairfax Medical Products Ltd 8
Pin, Retentive And Splinting, And Accessory Instruments Dentaurum GmbH & Co. KG 6
Bondent Coltene/Whaledent Gmbh & Co. KG 6
Core Forms Pulpdent Corporation 5
SRH3427LBlue Sky Bio, LLC Blue SKY BIO, LLC 5
Max Coltene/Whaledent Gmbh & Co. KG 4

Showing 12 of 62. All products under Pin, Retentive And Splinting, And Accessory Instruments

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