| Primary Device ID | E226100130768 |
| NIH Device Record Key | 94058378-6f1f-497b-82a8-e5df74853bdf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KOMET Dental Diamond Instruments |
| Version Model Number | KP6856XL.314.021.A2 |
| Catalog Number | KP6856XL.314.021 |
| Company DUNS | 317409001 |
| Company Name | Gebr. Brasseler GmbH & Co. KG |
| Device Count | 5 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E226100130761 [Primary] |
| HIBCC | E226100130768 [Unit of Use] |
| DZP | INSTRUMENT, DIAMOND, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E226100130768]
Moist Heat or Steam Sterilization
[E226100130768]
Moist Heat or Steam Sterilization
[E226100130768]
Moist Heat or Steam Sterilization
[E226100130768]
Moist Heat or Steam Sterilization
[E226100130768]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| E527042995DA2 | E392F.314.016.DA |
| E226100138998 | KP6863.314.014.A2 |
| E226100138968 | KP6863.314.016.A2 |
| E226100138938 | KP6878K.314.021.A2 |
| E226100138868 | KP6379E.314.029.A2 |
| E226100138838 | KP6368.314.016.A2 |
| E226100130798 | 4COMP.314.012.A2 |
| E226100130768 | KP6856XL.314.021.A2 |
| E226100125818 | BCD5.314.047.A2 |
| E226100125808 | BCD4S.314.049.A2 |
| E226100125798 | BCD4M.314.049.A2 |
| E226100105548 | BCD4L.314.049.A2 |
| E226100105538 | BCD3S.314.039.A2 |
| E226100105528 | BCD3M.314.039.A2 |
| E226100105518 | BCD3L.314.039.A2 |
| E226100105508 | BCD2.314.031.A2 |
| E226100105498 | BCD1.314.039.A2 |
| E226100085278 | 8972.314.020.A2 |
| E226100062908 | KP6370.314.035.A2 |
| E226100062608 | KP6879.314.012.A2 |
| E226100062508 | KP6881.314.016.A2 |
| E226100058448 | 868B.314.020.AU |
| E226100053551 | 6881.314.018.A1 |
| E226100053521 | 881.314.016.A1 |
| E226100052418 | 6888.314.012.AL |
| E226100041428 | ZR379.314.023.A2 |
| E226100041288 | ZR8379.314.023.A2 |
| E226100022952 | 5909SU.314.040.GS |
| E226100022932 | 8392SU.314.016.GS |
| E226100022922 | 8274SU.314.016.GS |
| E226100022912 | 8811SU.314.037.GS |
| E226100022902 | 8811SU.314.033.GS |
| E226100022892 | 6811SU.314.037.GS |
| E226100022882 | 6811SU.314.033.GS |
| E226100022872 | 5811SU.314.037.GS |
| E226100022862 | 5811SU.314.033.GS |
| E226100022852 | 8379SU.314.023.GS |
| E226100022842 | 8379SU.314.018.GS |
| E226100022832 | 379SU.314.023.GS |
| E226100022822 | 379SU.314.018.GS |
| E226100022812 | 6379SU.314.023.GS |
| E226100022802 | 6379SU.314.018.GS |
| E226100022792 | 5379SU.314.023.GS |
| E226100022782 | 5379SU.314.018.GS |
| E226100022772 | 8368SU.314.023.GS |
| E226100022762 | 8368SU.314.016.GS |
| E226100022542 | 368SU.314.023.GS |
| E226100022532 | 368SU.314.016.GS |
| E226100022522 | 6368SU.314.023.GS |
| E226100022512 | 6368SU.314.016.GS |