Markley Threaded Wire.064

One foot of stainless steel threaded wire that can be cut to length for pins and posts. The smaller diameter are used for dentin pins giving better retention to amalgam fillings on vital…

Registry build 21.09.26

One foot of stainless steel threaded wire that can be cut to length for pins and posts. The smaller diameter are used for dentin pins giving better retention to amalgam fillings on vital teeth. A variety of diameters are used for endo posts to strengthen and build up endodontically treated teeth. The threaded nature of the wire provides for better retention.

4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

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 Markley Threaded Wire.064
Listed by Almore Intl., Inc., United States
FDA product code EBL
Device type Pin, Retentive And Splinting, And Accessory Instruments
Device class Class 1
Regulation 21 CFR 872.3740
Premarket notification Exempt
Record published 2019-07-26
Record revised 2019-10-23 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes

Catalogue Numbers

Catalogue numbers for Markley Threaded Wire.064
Catalogue number Size Status
38064 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K830773 1983-04-28

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