Alpen Diamond Instruments

596 catalogue numbers from R1005, listed by Coltène/Whaledent AG, Switzerland, under Instrument, Diamond, Dental. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
596catalogue 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 Alpen Diamond Instruments
Listed by Coltène/Whaledent AG, Switzerland
FDA product code DZP
Device type Instrument, Diamond, Dental
Device class Class 1
Regulation 21 CFR 872.4535
Premarket notification Exempt
Record published 2024-01-12

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Alpen Diamond Instruments
Catalogue number Size Per pack Status
R1005 In distribution
RS848F018FG 10 In distribution
R880C012FG 5 In distribution
R860F014FG 5 In distribution
R392C021FG 5 In distribution
R134UF014FG 5 In distribution
R368EF023FG 5 In distribution
R859F014FG 5 In distribution
RS379C016FG 10 In distribution
R856L9C014FG 5 In distribution
R858UF012FG 5 In distribution
R836TC016FG 5 In distribution
R379UF023FG 5 In distribution
R835C014FG 5 In distribution
R878C012FG 5 In distribution
R379C016FG 5 In distribution
RS392C021FG 10 In distribution
R801SC018FG 5 In distribution
R3926EF016FG 5 In distribution
R879KSC018FG 5 In distribution
RS858EF012FG 10 In distribution
R837RF014FG 5 In distribution
R859F018FG 5 In distribution
R368C023FG 5 In distribution
R878KTC018FG 5 In distribution
R856SC014FG 5 In distribution
R850RF018FG 5 In distribution
R801C010FG 5 In distribution
R862EF010FG 5 In distribution
RS878KC014FG 10 In distribution
RS856C021FG 10 In distribution
RS3926EF016FG 10 In distribution
R834C016FG 5 In distribution
R132F008FG 5 In distribution
R877KC016FG 5 In distribution
RS847SC016FG 10 In distribution
RS859F014FG 10 In distribution
R135UF014FG 5 In distribution
RS881C010FG 10 In distribution
R860C010FG 5 In distribution
R8568TC016FG 5 In distribution
R855F014FG 5 In distribution
R379SC018FG 5 In distribution
R858F014FG 5 In distribution
R862F014FG 5 In distribution
R835RC008FG 5 In distribution
R392EF018FG 5 In distribution
RS856C018FG 10 In distribution
R835C008SS 5 In distribution
RS811C037FG 5 In distribution
RKS3SC016FG 5 In distribution
RS859C014FG 10 In distribution
R856LTC016FG 5 In distribution
RS848C018FG 10 In distribution
RS830LC016FG 10 In distribution
R850LC016FG 5 In distribution
R811SC037FG 5 In distribution
60018342 10 In distribution
RS801C014FG 10 In distribution
RS878KF010FG 10 In distribution
R858C012SS 5 In distribution
R836C014FG 5 In distribution
R852EF016FG 5 In distribution
60018398 10 In distribution
R838C012FG 5 In distribution
R905F031FG 5 In distribution
R828C030FG 5 In distribution
R848C023FG 5 In distribution
R801C010SS 5 In distribution
R878KF012FG 5 In distribution
R133UF010FG 5 In distribution
RS858UF012FG 10 In distribution
RS859UF010FG 10 In distribution
R837RSC012FG 5 In distribution
R878KSC023FG 5 In distribution
RS85010C018FG 10 In distribution
R878KSC016FG 5 In distribution
RS845C012FG 10 In distribution
R379C018FG 5 In distribution
RS863C016FG 10 In distribution
R859EF018FG 5 In distribution
R847TC018FG 5 In distribution
R856LSC016FG 5 In distribution
R848SC018FG 5 In distribution
R850C023FG 5 In distribution
R835RC010FG 5 In distribution
R834C021FG 5 In distribution
R8508TC018FG 5 In distribution
R811C048FG 5 In distribution
60018346 10 In distribution
RS862UF010FG 10 In distribution
RS368F016FG 10 In distribution
R379F018FG 5 In distribution
R855C014SS 5 In distribution
R368F023FG 5 In distribution
R885TC014FG 5 In distribution
R85010C018FG 5 In distribution
R368EF016FG 5 In distribution
R878KTC016FG 5 In distribution
60018411 10 In distribution
R856NSC014FG 5 In distribution
R882C014FG 5 In distribution
R848C016FG 5 In distribution
R884C012FG 5 In distribution
R856NC014FG 5 In distribution
R862F016FG 5 In distribution
R855TC014FG 5 In distribution
R879KTC021FG 5 In distribution
RS801C027FG 10 In distribution
R856LSC018FG 5 In distribution
R837RSC014FG 5 In distribution
R801EF023FG 5 In distribution
R862F012FG 5 In distribution
R132EF008FG 5 In distribution
R856SC021FG 5 In distribution
RS878KC016FG 10 In distribution
R390F014FG 5 In distribution
R379EF023FG 5 In distribution
R846TC016FG 5 In distribution
RS801C020FG 10 In distribution
RS852C012FG 10 In distribution
R856L10C014FG 5 In distribution
R889C009FG 5 In distribution
R846RC016FG 5 In distribution
R847TC016FG 5 In distribution
RS852C014FG 10 In distribution
R878C014FG 5 In distribution
RS878F010FG 10 In distribution
R86065C012FG 5 In distribution
R889MF007FG 5 In distribution
R899C027FG 5 In distribution
R855C025FG 5 In distribution
R3926F016FG 5 In distribution
RS879C016FG 10 In distribution
R851C016FG 5 In distribution
RS881C014FG 10 In distribution
RKS0C010FG 5 In distribution
R845RF025FG 5 In distribution
R8377C012FG 5 In distribution
60018467 5 In distribution
R813C014FG 5 In distribution
R864C014FG 5 In distribution
R847C016FG 5 In distribution
RS856F018FG 10 In distribution
R863C016FG 5 In distribution
RS801C018FG 10 In distribution
R855SC025FG 5 In distribution
R807C016FG 5 In distribution
RS855C010FG 10 In distribution
R847F016FG 5 In distribution
R379TC023FG 5 In distribution
R879KF012FG 5 In distribution
RS379C018FG 10 In distribution
R850RC018FG 5 In distribution
RS806C014FG 10 In distribution
R850LF016FG 5 In distribution
R863C012FG 5 In distribution
R6052C018FG 5 In distribution
R392F018FG 5 In distribution
R8567TC016FG 5 In distribution
R853C008FG 5 In distribution
R855SC014FG 5 In distribution
R849C016FG 5 In distribution
R839C012FG 5 In distribution
R133F010FG 5 In distribution
R863F012FG 5 In distribution
R878KC016FG 5 In distribution
R850LC018FG 5 In distribution
RS856LC012FG 10 In distribution
R6055SC018FG 5 In distribution
R839F014FG 5 In distribution
RS879C012FG 10 In distribution
R852F012FG 5 In distribution
RS878KC012FG 10 In distribution
R1001 In distribution
R848C012FG 5 In distribution
R8567C016SS 5 In distribution
R392F021FG 5 In distribution
RS8508SC018FG 10 In distribution
R368C016FG 5 In distribution
R805C010FG 5 In distribution
R3926C016FG 5 In distribution
R847SC014FG 5 In distribution
R839F012FG 5 In distribution
R8496C012FG 5 In distribution
60018468 5 In distribution
R847RC016FG 5 In distribution
R855F012FG 5 In distribution
R862C010FG 5 In distribution
RS801C029FG 10 In distribution
RS858C012FG 10 In distribution
RS850F014FG 10 In distribution
RS8568C016FG 10 In distribution
R881C010FG 5 In distribution
R877KC014FG 5 In distribution
R859F010FG 5 In distribution
R856SC025FG 5 In distribution
R878KTC014FG 5 In distribution
R856C018FG 5 In distribution
R1004 In distribution
R8378C012FG 5 In distribution
R879KTC014FG 5 In distribution
R888F012FG 5 In distribution
60018367 10 In distribution
R852C016FG 5 In distribution
R878KC012FG 5 In distribution
R878KF010FG 5 In distribution
R881C014FG 5 In distribution
R859UF024FG 5 In distribution
R134EF014FG 5 In distribution
RS856F021FG 10 In distribution
R886C016FG 5 In distribution
RS881F016FG 10 In distribution
R805C014FG 5 In distribution
R379C023FG 5 In distribution
R135EF014FG 5 In distribution
R6051SC018FG 5 In distribution
R859C024FG 5 In distribution
RS849C016FG 10 In distribution
R847C012FG 5 In distribution
R835C012FG 5 In distribution
R836TC014FG 5 In distribution
RS859C021FG 10 In distribution
R881TC014FG 5 In distribution
RS801C016FG 10 In distribution
RS856TC014FG 10 In distribution
R859C010FG 5 In distribution
R879KC023FG 5 In distribution
R8467C016FG 5 In distribution
R850C014FG 5 In distribution
RS859EF018FG 10 In distribution
60018403 10 In distribution
R858EF012FG 5 In distribution
R847SC016FG 5 In distribution
R859UF018FG 5 In distribution
R848TC018FG 5 In distribution
R830LC016FG 5 In distribution
R859C018FG 5 In distribution
RKS4F024FG 5 In distribution
R886C012FG 5 In distribution
R885C012SS 5 In distribution
R836C012FG 5 In distribution
R836RC012FG 5 In distribution
RS847C012FG 10 In distribution
RS847SC018FG 10 In distribution
60018395 10 In distribution
R845C010FG 5 In distribution
R830LC014FG 5 In distribution
R878KC014FG 5 In distribution
R847C025FG 5 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MDT Diamond Coated Dental Burs M.D.T. – Micro Diamond Technologies Ltd. 31,050
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