Komet Dental Diamond Instruments

1,610 catalogue numbers from 5368SU.314.023.GS, listed by Gebr. Brasseler Gmbh & Co. KG, Germany, 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
1,610catalogue 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 Komet Dental Diamond Instruments
Listed by Gebr. Brasseler Gmbh & Co. KG, Germany
FDA product code DZP
Device type Instrument, Diamond, Dental
Device class Class 1
Regulation 21 CFR 872.4535
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-02-01
Record revised 2024-11-12 (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
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 25, pack of 10
Distribution end date 2025-07-04
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Komet Dental Diamond Instruments
Catalogue number Size Per pack Status
5368SU.314.023.GS In distribution
8837.314.012.A2 5 In distribution
OS20FH.000.140.A1 In distribution
8368.314.021.A2 5 In distribution
6856LSU.314.018.GS In distribution
801.314.014.A2 5 In distribution
8862.314.012.A2 5 In distribution
6879K.314.021.A2 5 In distribution
850.314.012.A1 In distribution
S6863.314.014.A2 5 In distribution
S5881.314.016.A2 5 In distribution
845KRD.314.025.A2 5 In distribution
5379.314.018.A2 5 In distribution
S6979K.314.018.A2 5 In distribution
830L.314.018.A2 5 In distribution
6879K.314.023.A2 5 In distribution
859.314.010.AU 5 In distribution
6877K.314.018.A2 5 In distribution
OS20F.000.140.A1 In distribution
8856SU.314.018.GS In distribution
6848.314.016.A2 5 In distribution
ZR6801.314.018.A2 5 In distribution
6835.313.012.A2 5 In distribution
8972.314.020.A2 5 In distribution
8888SU.314.012.GS In distribution
6847KR.313.018.A2 5 In distribution
835.314.010.A2 5 In distribution
KP6830L.315.014.A2 5 In distribution
369.314.025.A2 5 In distribution
835KR.314.008.A1 In distribution
905.313.027.A2 5 In distribution
KS2SC.313.014.A2 5 In distribution
848.314.016.A2 5 In distribution
S6801.314.023.A2 5 In distribution
S5847KR.314.016.A1 In distribution
KP6862.314.016.A2 5 In distribution
6801.314.023.A2 5 In distribution
6855.314.025.A2 5 In distribution
5805.314.016.A2 5 In distribution
8370.314.030.A2 5 In distribution
379SU.314.018.GS In distribution
837KR.314.012.A6 100 In distribution
8879.314.014.A2 5 In distribution
8856.314.014.A1 In distribution
S5847KR.314.018.A2 5 In distribution
KP6881.314.012.A2 5 In distribution
6806.314.010.A2 5 In distribution
379.314.014.A2 5 In distribution
SF8878KD.000.018.A1 In distribution
835.314.008.A2 5 In distribution
5848.314.018.A2 5 In distribution
8850SU.314.018.GS In distribution
868.314.016.A2 5 In distribution
835KRM.314.008.A2 5 In distribution
KP6830RL.314.012.A2 5 In distribution
8957.314.009.A2 5 In distribution
6856SU.314.018.GS In distribution
881.314.010.A2 5 In distribution
5856.314.018.A2 5 In distribution
SF8878KM.000.018.A1 In distribution
S6368.314.023.A2 5 In distribution
8856.314.012.A2 5 In distribution
847.314.012.A2 5 In distribution
8905.313.023.AU 5 In distribution
8955.314.008.A2 5 In distribution
6801.314.023.AU 5 In distribution
2368.314.023.A2 5 In distribution
830RLA.314.033.A2 5 In distribution
6801.314.012.A2 5 In distribution
OS1F.000.140.A1 In distribution
8878KSU.314.012.GS In distribution
BCD3S.314.039.A2 5 In distribution
OS18MHE.000.110.A1 In distribution
8856.314.014.A6 100 In distribution
953AM.314.014.A2 5 In distribution
S6862.314.016.A2 5 In distribution
5858.313.014.A2 5 In distribution
8885.314.012.A2 5 In distribution
5909.314.040.AK 5 In distribution
10839.314.014.A2 5 In distribution
6879.314.016.A2 5 In distribution
8845KR.314.025.A1 In distribution
876K.314.012.A2 5 In distribution
863.314.016.A2 5 In distribution
2856.314.018.A2 5 In distribution
836.314.012.A2 5 In distribution
6811SU.314.037.GS In distribution
8850.314.016.A6 100 In distribution
850.314.012.A2 5 In distribution
116D.204. 1.A1 In distribution
5837KR.314.014.A2 5 In distribution
8905.313.031.A2 5 In distribution
SF856.000.018.A1 In distribution
8889M.314.007.A2 5 In distribution
T5878.314.012.A2 5 In distribution
8856L.314.016.G1 5 In distribution
852.314.012.A1 In distribution
8858SU.314.014.GS In distribution
ZR6856.314.025.A2 5 In distribution
8859.314.014.A2 5 In distribution
6881.314.014.A2 5 In distribution
6813SU.314.014.GS In distribution
2979.314.018.A2 5 In distribution
6850.314.023.A2 5 In distribution
5856.314.012.A2 5 In distribution
839.314.012.A6 100 In distribution
860.314.016.A2 5 In distribution
6856L.314.020.A1 In distribution
807.314.012.A2 5 In distribution
856SU.314.018.GS In distribution
5855SU.314.016.GS In distribution
6837.313.012.A2 5 In distribution
KP6847KR.314.018.A2 5 In distribution
6888.314.012.AL 100 In distribution
5850.313.016.A2 5 In distribution
8856.314.021.A2 5 In distribution
8837KR.314.014.A2 5 In distribution
8859.314.018.A2 5 In distribution
2847KR.314.018.A2 5 In distribution
5811SU.314.037.GS In distribution
6847KRD.314.016.A2 5 In distribution
846KR.312.016.A2 5 In distribution
8379.314.023.A6 100 In distribution
S6835KR.314.012.A2 5 In distribution
856SU.314.016.GS In distribution
830.314.009.A2 5 In distribution
863.314.012.A2 5 In distribution
KP6836KR.314.014.A2 5 In distribution
850.314.012.AU 5 In distribution
ZR379L.315.014.A2 5 In distribution
8856L.314.018.A1 In distribution
370.314.030.A2 5 In distribution
858.314.014.A2 5 In distribution
837L.314.014.A2 5 In distribution
837.314.012.AU 5 In distribution
8801.314.023.A2 5 In distribution
878KXC.314.018.A2 5 In distribution
6379SU.314.018.GS In distribution
8379.314.018.AU 5 In distribution
6850.314.012.A2 5 In distribution
8863SU.314.012.GS In distribution
818.314.050.A2 5 In distribution
856.314.018.G1 5 In distribution
6878K.314.014.A1 In distribution
KS0.314.010.A2 5 In distribution
6878K.313.018.A2 5 In distribution
805.314.014.AU 5 In distribution
S6878K.314.018.A2 5 In distribution
878K.314.021.A2 5 In distribution
881.314.010.A1 In distribution
6845KRSU.314.016.GS In distribution
813.314.010.A2 5 In distribution
877.314.009.A2 5 In distribution
8392SU.314.016.GS In distribution
801.316.010.A2 5 In distribution
860.314.010.A2 5 In distribution
8877K.314.016.A2 5 In distribution
836KR.314.014.A2 5 In distribution
KS3SC.314.016.A2 5 In distribution
856LSU.314.016.GS In distribution
856.314.018.A2 5 In distribution
905.313.031.A2 5 In distribution
8859SU.314.016.GS In distribution
856P.314.018.A2 5 In distribution
856XC.314.021.A1 In distribution
877.314.010.A2 5 In distribution
849.314.009.A2 5 In distribution
856L.314.014.AU 5 In distribution
8856L.314.018.AU 5 In distribution
8852.314.014.A2 5 In distribution
5856.314.016.G1 5 In distribution
8856P.314.021.A2 5 In distribution
6878K.313.016.A2 5 In distribution
5850.314.012.G1 5 In distribution
5878K.313.016.A2 5 In distribution
956UF.314.010.A2 5 In distribution
805SU.314.014.GS In distribution
OS1M.000.140.A1 In distribution
5368.314.016.A2 5 In distribution
6879K.314.012.A1 In distribution
878KP.314.021.A2 5 In distribution
850SU.314.014.GS In distribution
S6862.314.012.A1 In distribution
5379.314.023.AK 5 In distribution
CEZ80221.104.220.AM In distribution
5856LSU.314.018.GS In distribution
2855.314.025.A2 5 In distribution
8856.314.016.A1 In distribution
859EF.314.014.A2 5 In distribution
6801.314.016.A1 In distribution
6836KR.314.014.A2 5 In distribution
858.314.010.A2 5 In distribution
OS1FV.000.140.A1 In distribution
S6848KR.314.018.A2 5 In distribution
6880.314.012.A2 5 In distribution
S5879.314.014.A2 5 In distribution
KP6877.314.016.A2 5 In distribution
880.314.014.A2 5 In distribution
6849.314.012.A2 5 In distribution
835.314.008.AU 5 In distribution
5811SU.314.033.GS In distribution
856.314.014.A2 5 In distribution
8856L.314.014.A2 5 In distribution
8801.314.029.A2 5 In distribution
2979K.314.021.A2 5 In distribution
6847KR.314.018.G1 5 In distribution
T5879K.314.018.A2 5 In distribution
862EF.314.012.A2 5 In distribution
ZR8881.315.016.A2 5 In distribution
847KR.314.016.A6 100 In distribution
KS1SC.313.012.A2 5 In distribution
6856.314.021.A2 5 In distribution
KP6379E.314.029.A2 5 In distribution
8858.314.014.A2 5 In distribution
8856.314.016.AU 5 In distribution
8847.314.014.A2 5 In distribution
5862.313.014.A2 5 In distribution
6801.314.014.A2 5 In distribution
6878K.314.018.G1 5 In distribution
ZR6801.314.014.A2 5 In distribution
837.314.016.A2 5 In distribution
S6863.314.016.A2 5 In distribution
4COMP.314.012.A2 5 In distribution
8881.314.016.A2 5 In distribution
6848.314.014.A2 5 In distribution
8905.313.018.A2 5 In distribution
379XC.314.023.A2 5 In distribution
S5878.314.016.A2 5 In distribution
6850SU.314.012.GS In distribution
379.312.023.A1 In distribution
6856L.314.018.A1 In distribution
SF979.000.016.A1 In distribution
6801SU.314.023.GS In distribution
5847.314.018.A2 5 In distribution
S6882.314.012.A2 5 In distribution
ZR972.314.020.A2 5 In distribution
KS4F.314.024.A2 5 In distribution
OS2F.000.140.A1 In distribution
801SU.314.014.GS In distribution
6856LSU.314.016.GS In distribution
5869.314.014.A2 5 In distribution
845KR.314.025.A2 5 In distribution
8847KR.314.018.A2 5 In distribution
8860L.314.012.A2 5 In distribution
5878K.314.021.A2 5 In distribution
952.900.100.A2 5 In distribution
KP6878K.314.021.A2 5 In distribution
2886.314.016.A2 5 In distribution
S6879K.314.018.A2 5 In distribution
OS18MV.000.110.A1 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
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