Darby Dental Supply, LLC

Endo Access DIA SE 165-014 DFM5978C

Registry build 21.09.26
7manufacturers in China registered for this device type
295catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DZP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Huizhou Videya Technology Co., Ltd. Huizhou Guangdong Manufacturer 18
Shenzhen Superline Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 12
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. Zhangzhou Henan Manufacturer 6

Record

Regulatory record for Darby Dental Supply, LLC
Listed by Darby Dental Supply, LLC
FDA product code DZP
Device type Instrument, Diamond, Dental
Device class Class 1
Regulation 21 CFR 872.4535
Premarket notification Exempt
Record published 2018-10-31
Record revised 2020-03-23 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Darby Dental Supply, LLC
Catalogue number Size Per pack Status
9526051 5 In distribution
9526016 5 In distribution
9526336 5 In distribution
5257077 5 In distribution
9526787 5 In distribution
9526419 5 In distribution
9526061 5 In distribution
9510086 5 In distribution
9581340 5 In distribution
9594870 25 In distribution
9526216 5 In distribution
9594806 25 In distribution
9526536 5 In distribution
9526691 5 In distribution
9527561 5 In distribution
5257047 5 In distribution
5257064 5 In distribution
9526786 5 In distribution
9526561 5 In distribution
9594876 25 In distribution
9526284 5 In distribution
9511126 5 In distribution
9526636 5 In distribution
9526306 5 In distribution
9581346 5 In distribution
9526282 5 In distribution
9526581 5 In distribution
9526105 5 In distribution
9594830 25 In distribution
9581344 5 In distribution
9526616 5 In distribution
5257060 5 In distribution
9526146 5 In distribution
9527509 5 In distribution
9526496 5 In distribution
9526626 5 In distribution
9526286 5 In distribution
9594826 25 In distribution
9526545 5 In distribution
9526236 5 In distribution
9594856 25 In distribution
5257050 5 In distribution
9527623 5 In distribution
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9594866 25 In distribution
9526526 5 In distribution
9580280 In distribution
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9527612 5 In distribution
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9527531 5 In distribution
9581348 5 In distribution
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9594810 25 In distribution
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9594807 25 In distribution
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9594846 25 In distribution
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9594812 25 In distribution
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5250408 25 In distribution
9526411 5 In distribution
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5257084 5 In distribution
9526280 5 In distribution
9526516 5 In distribution
5257074 5 In distribution
5257079 5 In distribution
9526541 5 In distribution
9594872 25 In distribution
9527553 5 In distribution
5257081 5 In distribution
9527606 5 In distribution
9594840 25 In distribution
9594820 25 In distribution
9594858 25 In distribution

Showing 250 of 295 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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MDT Diamond Coated Dental Burs -Sterile M.D.T. – Micro Diamond Technologies Ltd. 3,719
FG diamond DFS-Diamon Gmbh 2,527
Horico Hopf, Ringleb & Co. Gmbh & CIE. 2,320
Two Striper Abrasive Technology, LLC 2,294
Sunshine Diamonds DR. Hopf Gmbh & Co. KG 2,240
Brasseler USA Peter Brasseler Holdings, LLC 2,016
Edenta Edenta Etablissement 1,831
Instrument, Diamond, Dental Hager & Meisinger Gesellschaft mit beschränkter Haftung 1,827
Jota Jota AG 1,615
Komet Dental Diamond Instruments Gebr. Brasseler Gmbh & Co. KG 1,610
dental diamond bur Strauss & Co – Industrial Diamonds Ltd 1,456

Showing 12 of 366. All products under Instrument, Diamond, Dental

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