| Primary Device ID | D87745080SHINE121 |
| NIH Device Record Key | 8efc289e-97fa-4ade-84e7-a716737e5bb4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dental Bur Kit |
| Version Model Number | 45080SHINE1-2 |
| Catalog Number | 45080SHINE1-2 |
| Company DUNS | 600028195 |
| Company Name | STRAUSS & CO - INDUSTRIAL DIAMONDS LTD |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D87745080SHINE121 [Primary] |
| DZP | Instrument, Diamond, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-06 |
| Device Publish Date | 2024-07-29 |
| D87745967ACSET11 | All Ceram Set |
| D87745332KIT11 | DEGRANULATION & SHAPING BUR INTRO KIT ATT |
| D87745322GRKIT11 | Degranulation Set Laser Mark For |
| D87745080WGR3D427PACK1 | OPTIMUM DEGRNLTN BUR 3MM PK3 |
| D87745080WGR35D427PA1 | OPTIMUM DEGRNLTN BUR 3.5MM PK3 |
| D87745080WGR25D427PA1 | OPTIMUM DEGRNLTN BUR 2.5MM PK3 |
| D87745080SHINE121 | OPTIMUM COMPOSITE KIT PREMIUM SET |
| D87745080PLSET11 | OPTIMUM PORCELAIN LAMINATE SET |
| D87745080GRKIT31 | OPTIMUM DEGRANULATION KIT |
| D87745080ENDOSET11 | OPTIMUM ENDODONTIC SET |
| D87745080CPSET21 | OPTIMUM CROWN & BRIDGE PREP SET |
| D87745080COMSET11 | OPTIMUM COMPOSITE FINISHING SET |