| Primary Device ID | E226039954A11 |
| NIH Device Record Key | fb21e4c3-f74a-4bb3-8935-fb8f95041d6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KOMET Dental Ceramic Burs |
| Version Model Number | K1SM.204.012.A1 |
| Catalog Number | K1SM.204.012 |
| Company DUNS | 317409001 |
| Company Name | Gebr. Brasseler GmbH & Co. KG |
| Device Count | 1 |
| 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 | E226039954A11 [Primary] |
| EJL | BUR, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E226039954A11]
Moist Heat or Steam Sterilization
[E226039954A11]
Moist Heat or Steam Sterilization
[E226039954A11]
Moist Heat or Steam Sterilization
[E226039954A11]
Moist Heat or Steam Sterilization
[E226039954A11]
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 |
| E226041256A11 | K1SM.204.027.A1 |
| E226039959A11 | K1SM.205.021.A1 |
| E226039958A11 | K1SM.205.016.A1 |
| E226039957A11 | K1SM.205.012.A1 |
| E226039956A11 | K1SM.204.021.A1 |
| E226039955A28 | K1SM.204.016.A2 |
| E226039955A11 | K1SM.204.016.A1 |
| E226039954A28 | K1SM.204.012.A2 |
| E226039954A11 | K1SM.204.012.A1 |
| E226038954A11 | K1SM.205.023.A1 |
| E226038953A11 | K1SM.205.018.A1 |
| E226038952A11 | K1SM.205.014.A1 |
| E226038951A11 | K1SM.205.010.A1 |
| E226038617A12 | KT.314.016.A1 |
| E226036974A28 | K1SM.204.023.A2 |
| E226036973A28 | K1SM.204.018.A2 |
| E226036973A11 | K1SM.204.018.A1 |
| E226036972A28 | K1SM.204.014.A2 |
| E226036972A11 | K1SM.204.014.A1 |
| E226036971A28 | K1SM.204.010.A2 |
| E226036971A11 | K1SM.204.010.A1 |
| E226036974A11 | K1SM.204.023.A1 |