| Primary Device ID | E226007186R18 |
| NIH Device Record Key | 7f4f9e4e-5166-4aac-9414-b2282eab75ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KOMET Root Canal Files |
| Version Model Number | 17325.654.030.R1 |
| Catalog Number | 17325.654.030 |
| Company DUNS | 317409001 |
| Company Name | Gebr. Brasseler GmbH & Co. KG |
| Device Count | 6 |
| 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 | true |
| 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 | E226007186R11 [Primary] |
| HIBCC | E226007186R18 [Unit of Use] |
| EKS | FILE, PULP CANAL, ENDODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-05 |
| Device Publish Date | 2025-05-28 |
| E226100106048 | PRQ4L31.204.050.G1 |
| E226100106028 | PRQ4L31.204.045.G1 |
| E226100106008 | PRQ5L31.204.040.G1 |
| E226100105988 | PRQ5L31.204.035.G1 |
| E226100105968 | PRQ6L31.204.030.G1 |
| E226100105948 | PRQ6L31.204.025.G1 |
| E226100105928 | PRQ6L31.204.020.G1 |
| E226100105908 | PRQ4L25.204.050.G1 |
| E226100105888 | PRQ4L25.204.045.G1 |
| E226100105868 | PRQ5L25.204.040.G1 |
| E226100105848 | PRQ5L25.204.035.G1 |
| E226100105828 | PRQ6L25.204.030.G1 |
| E226100105808 | PRQ6L25.204.025.G1 |
| E226100105788 | PRQ6L25.204.020.G1 |
| E226100105768 | PRQ4L21.204.050.G1 |
| E226100105738 | PRQ4L21.204.045.G1 |
| E226100105688 | PRQ5L21.204.040.G1 |
| E226100105648 | PRQ5L21.204.035.G1 |
| E226100105628 | PRQ6L21.204.030.G1 |
| E226100105608 | PRQ6L21.204.025.G1 |
| E226100105588 | PRQ6L21.204.020.G1 |
| E226100090778 | RE05L25.204.025.G1 |
| E226100090768 | RE05L21.204.025.G1 |
| E226100090758 | RE10L15.204.030.G1 |
| E226100027348 | OPR08L19.204.025.G1 |
| E226048921G18 | OP10L15.204.030.G1 |
| E226048579G18 | PG03L31.204.020.G1 |
| E226048578G18 | PG03L31.204.015.G1 |
| E226048435G18 | OP08L19.204.025.G1 |
| E226047492G18 | PG03L21.204.020.G1 |
| E226047491G18 | PG03L21.204.015.G1 |
| E226046911G18 | OP10L19.204.030.G1 |
| E226046838G18 | PG03L25.204.020.G1 |
| E226046802G18 | F06L31.204.035.G1 |
| E226046801G18 | F06L25.204.035.G1 |
| E226046800G18 | F06L21.204.035.G1 |
| E226046720G18 | F06L31.204.040.G1 |
| E226046719G18 | F06L31.204.030.G1 |
| E226046718G18 | F06L31.204.025.G1 |
| E226046717G18 | F06L31.204.020.G1 |
| E226046716G18 | F06L25.204.040.G1 |
| E226046715G18 | F06L25.204.030.G1 |
| E226046714G18 | F06L25.204.025.G1 |
| E226046713G18 | F06L25.204.020.G1 |
| E226046712G18 | F06L21.204.040.G1 |
| E226046711G18 | F06L21.204.030.G1 |
| E226046710G18 | F06L21.204.025.G1 |
| E226046709G18 | F06L21.204.020.G1 |
| E226045001G18 | PG03L25.204.015.G1 |
| E226044151G18 | F04L31.204.055.G1 |