Darby Dental Supply, LLC

Fiber Post Parallel Refill #2 Darby

Registry build 21.09.26
10manufacturers in China registered for this device type
90catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code ELR
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
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Alwings Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 39
Henan Lusterdent Medical Instrument Co., Ltd. Zhengzhou Henan Manufacturer 15
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9

Record

Regulatory record for Darby Dental Supply, LLC
Listed by Darby Dental Supply, LLC
FDA product code ELR
Device type Post, Root Canal
Device class Class 1
Regulation 21 CFR 872.3810
Premarket notification Exempt
Record published 2018-08-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Darby Dental Supply, LLC
Catalogue number Size Per pack Status
9520864 10 In distribution
9539324 6 In distribution
9539222 12 In distribution
9520873 10 In distribution
9520954 10 In distribution
9539326 6 In distribution
9520929 100 In distribution
9539217 12 In distribution
9520937 25 In distribution
9520863 In distribution
9539321 6 In distribution
9539228 12 In distribution
9520332 100 In distribution
9520875 10 In distribution
9520860 In distribution
9520951 10 In distribution
9539223 12 In distribution
9520331 100 In distribution
9539318 6 In distribution
9539230 12 In distribution
9539225 12 In distribution
9520950 In distribution
9520867 In distribution
9539224 12 In distribution
9539331 6 In distribution
9520956 10 In distribution
9520866 10 In distribution
9539330 6 In distribution
9520325 25 In distribution
9520948 10 In distribution
9539227 12 In distribution
9539210 240 In distribution
9539235 12 In distribution
9539319 6 In distribution
9539250 2 In distribution
9520330 100 In distribution
9520928 In distribution
9520874 10 In distribution
9520957 10 In distribution
9520955 10 In distribution
9520870 In distribution
9539332 6 In distribution
9539218 12 In distribution
9539221 12 In distribution
9539233 12 In distribution
9539231 12 In distribution
9520861 In distribution
9520946 10 In distribution
9539232 12 In distribution
9520327 25 In distribution
9520865 10 In distribution
9539317 6 In distribution
9539327 6 In distribution
9520871 In distribution
9539316 6 In distribution
9520945 10 In distribution
9539200 60 In distribution
9539229 12 In distribution
9539334 6 In distribution
9520938 25 In distribution
9520952 10 In distribution
9539216 12 In distribution
9520930 100 In distribution
9520943 10 In distribution
9520862 In distribution
9520869 In distribution
9520336 25 In distribution
9539322 6 In distribution
9539325 6 In distribution
9520947 10 In distribution
9539333 6 In distribution
9539226 12 In distribution
9520328 25 In distribution
9520940 25 In distribution
9520868 In distribution
9539315 6 In distribution
9539328 6 In distribution
9520944 10 In distribution
9539215 12 In distribution
9539300 60 In distribution
9539219 12 In distribution
9520953 10 In distribution
9520939 25 In distribution
9539320 6 In distribution
9539323 6 In distribution
9520872 10 In distribution
9520337 100 In distribution
9539329 6 In distribution
9520936 25 In distribution
9520335 25 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 115
ParaPost XP Coltene/Whaledent Gmbh & Co. KG 111
Hahnenkratt E. Hahnenkratt Gmbh 89
Surtex Dentatus AB 84
ParaPost Coltene/Whaledent Gmbh & Co. KG 46
Brasseler USA Peter Brasseler Holdings, LLC 44
Two Striper Abrasive Technology, LLC 43
Johnson-Promident Young Innovations Inc. 41
Flexi-Post Essential Dental Systems, Inc. 40
Biolight Synca Marketing 37
Integra® Miltex® Integra LifeSciences Production Corporation 37
Endodontic Posts Rhein 83 SRL 31

Showing 12 of 231. All products under Post, Root Canal

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