Instrument, Diamond, Dental

Rotary diamond instrument for dental application, single-use, sterile

Registry build 21.09.26
7manufacturers in China registered for this device type
1,827catalogue 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 Instrument, Diamond, Dental
Listed by Hager & Meisinger Gesellschaft mit beschränkter Haftung
FDA product code DZP
Device type Instrument, Diamond, Dental
Device class Class 1
Regulation 21 CFR 872.4535
Premarket notification Exempt
Record published 2021-09-15
Record revised 2024-12-12 (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, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Instrument, Diamond, Dental
Catalogue number Size Per pack Status
411G 018 2 In distribution
838 010 5 In distribution
846KR 023 2 In distribution
MO868G-016-FG 25 In distribution
806 009 5 In distribution
MO863G-012-FG 25 In distribution
2413 In distribution
351610VF 25 In distribution
MO859-010-FG 25 In distribution
801LD 030 2 In distribution
1916C 25 In distribution
861 012 5 In distribution
510W 030 5 In distribution
B878 016 5 In distribution
15168C 25 In distribution
836G 014 5 In distribution
830P 018 5 In distribution
808LF 014 5 In distribution
895F 016 5 In distribution
846 016 5 In distribution
898U 014 5 In distribution
849LF 012 5 In distribution
837G 014 5 In distribution
846RG 018 5 In distribution
M895 007 5 In distribution
863KG 012 5 In distribution
868G 012 5 In distribution
MO881G-014-FG 25 In distribution
847 014 5 In distribution
MO833F-018-FG 25 In distribution
0508MS 25 In distribution
2565M In distribution
830C 021 5 In distribution
MO858G-014-FG 25 In distribution
859L 010 5 In distribution
847RH 018 5 In distribution
878 016 5 In distribution
MO837F-014-FG 25 In distribution
879F 014 5 In distribution
801U 012 5 In distribution
MO881C-012-FG 25 In distribution
831G 016 5 In distribution
MO809-008-FG 25 In distribution
830G 025 5 In distribution
899 021 5 In distribution
862U 012 5 In distribution
12148C 25 In distribution
814 031 5 In distribution
819 014 5 In distribution
909 060 2 In distribution
801G 018 5 In distribution
891 014 5 In distribution
809R 010 5 In distribution
848C 016 5 In distribution
898 014 5 In distribution
801 033 5 In distribution
805 021 5 In distribution
808RG 016 5 In distribution
846 014 5 In distribution
849LC 012 5 In distribution
811LG 037 2 In distribution
859 018 5 In distribution
MO851L-018-FG 25 In distribution
17188C 25 In distribution
835G 012 5 In distribution
801 012 5 In distribution
845 014 5 In distribution
833C 016 5 In distribution
809RG 012 5 In distribution
MO863F-014-FG 25 In distribution
856H 018 5 In distribution
801 025 5 In distribution
03185C 25 In distribution
842H 018 5 In distribution
18048C 25 In distribution
862G 012 5 In distribution
805G 010 5 In distribution
841F 012 5 In distribution
351210VF 25 In distribution
801H 050 2 In distribution
1900M 25 In distribution
509F 014 5 In distribution
09149C 25 In distribution
805G 018 5 In distribution
MO846F-016-FG 25 In distribution
0710M 25 In distribution
809RH 014 5 In distribution
848W 018 5 In distribution
859 018 5 In distribution
907G 041 5 In distribution
MO845R-025-FG 25 In distribution
848Z5 024 5 In distribution
837LH 014 5 In distribution
MO842F-014-FG 25 In distribution
801 021 5 In distribution
881C 012 5 In distribution
B852 018 5 In distribution
878F 016 5 In distribution
862 014 5 In distribution
835 007 5 In distribution
846RH 016 5 In distribution
15108F 25 In distribution
MO842F-012-FG 25 In distribution
840H 014 5 In distribution
MO852-012-FG 25 In distribution
830LU 014 5 In distribution
855C 018 5 In distribution
Z818G 060 5 In distribution
801 012 5 In distribution
801L 014 5 In distribution
0508M 25 In distribution
830F 018 5 In distribution
847 014 5 In distribution
801G 012 5 In distribution
801H 016 5 In distribution
83804 012 5 In distribution
846 018 5 In distribution
837LH 014 5 In distribution
849G 014 5 In distribution
867F 009 5 In distribution
805G 014 5 In distribution
852F 012 5 In distribution
ZCS24 In distribution
17168M 25 In distribution
B879 016 5 In distribution
IRC03 In distribution
828R 009 5 In distribution
MO852F-012-FG 25 In distribution
863F 018 5 In distribution
0123F 25 In distribution
15189C 25 In distribution
879 023 5 In distribution
863C 012 5 In distribution
15093M 25 In distribution
802KG 014 5 In distribution
806 016 5 In distribution
854 025 5 In distribution
834W 018 5 In distribution
838F 010 5 In distribution
15093F 25 In distribution
2450 In distribution
869F 014 5 In distribution
801H 029 5 In distribution
908 032 5 In distribution
846G 012 5 In distribution
11166CS 25 In distribution
MO850F-012-FG 25 In distribution
17188F 25 In distribution
852C 016 5 In distribution
833U 023 5 In distribution
825 050 2 In distribution
860G 010 5 In distribution
801 009 5 In distribution
801C 012 5 In distribution
855G 012 5 In distribution
847H 016 5 In distribution
862C 014 5 In distribution
863C 016 5 In distribution
885G 014 5 In distribution
842G 018 5 In distribution
805 018 5 In distribution
847R 016 5 In distribution
855LF 009 5 In distribution
801 021 5 In distribution
835F 008 5 In distribution
878P 014 5 In distribution
830H 018 5 In distribution
MO801-023-FG 25 In distribution
801 007 5 In distribution
MO852Z3-024-FG 25 In distribution
855 016 5 In distribution
MO868C-012-FG 25 In distribution
801 016 5 In distribution
837RF 012 5 In distribution
801H 050 2 In distribution
857G 014 5 In distribution
MO808L-016-FG 25 In distribution
885 012 5 In distribution
11146CS 25 In distribution
809R 018 5 In distribution
805 021 5 In distribution
801H 031 5 In distribution
889LF 009 5 In distribution
880 010 5 In distribution
801G 023 5 In distribution
909 060 2 In distribution
868F 010 5 In distribution
869L 014 5 In distribution
862 012 5 In distribution
846C 014 5 In distribution
842G 010 5 In distribution
858F 014 5 In distribution
801 016 5 In distribution
830 018 5 In distribution
MO881-010-FG 25 In distribution
850F 014 5 In distribution
MO867F-009-FG 25 In distribution
845RF 025 5 In distribution
878G 018 5 In distribution
885F 012 5 In distribution
DB02 In distribution
881G 016 5 In distribution
2424CS 25 In distribution
897WH 020 5 In distribution
MO837F-012-FG 25 In distribution
835H 010 5 In distribution
849LU 012 5 In distribution
13103F 25 In distribution
848 031 2 In distribution
862 010 5 In distribution
MO838G-014-FG 25 In distribution
808R 014 5 In distribution
856 014 5 In distribution
852F 014 5 In distribution
851LF 012 5 In distribution
852Z2 024 5 In distribution
863G 012 5 In distribution
MO869F-014-FG 25 In distribution
MO859-014-FG 25 In distribution
D407L 010 2 In distribution
877H 018 5 In distribution
809RG 010 5 In distribution
878F 012 5 In distribution
841 010 5 In distribution
805 012 5 In distribution
848WF 018 5 In distribution
1900C 25 In distribution
856 016 5 In distribution
837G 012 5 In distribution
859L 014 5 In distribution
808RF 014 5 In distribution
840G 016 5 In distribution
MO859L-014-FG 25 In distribution
862F 014 5 In distribution
847KR 016 5 In distribution
801G 029 5 In distribution
510W 035 5 In distribution
13148M 25 In distribution
CLK01 In distribution
818 045 2 In distribution
850H 025 5 In distribution
897WF 016 5 In distribution
837F 016 5 In distribution
850G 023 5 In distribution
MO868-008-FG 25 In distribution
859 012 5 In distribution
809RF 014 5 In distribution
83808 018 5 In distribution
837LH 012 5 In distribution
870 018 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
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
NTI NTI-Kahla Gmbh, Rotary Dental Instruments 1,014

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