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.
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.
| 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
| 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
| 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 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
| 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.