| Primary Device ID | D87745080FGCERK0RPACED1 |
| NIH Device Record Key | cbaa1f66-e185-406f-a21f-e33bda7d1323 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ceramic Dental bur |
| Version Model Number | 45080FG-CER-K0R-PACKED |
| Catalog Number | 45080FG-CER-K0R-PACKED |
| 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 | true |
| 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 | D87745080FGCERK0RPACED1 [Primary] |
| DZP | Instrument, Diamond, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
[D87745080FGCERK0RPACED1]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-24 |
| Device Publish Date | 2025-12-16 |
| D87745080FGCERK2RPACED1 | Optimum® Ceramic Soft Tissue Trimmer - Implant Uncovering Bur - Big |
| D87745080FGCERK0RPACED1 | Optimum® Ceramic Soft Tissue Trimmer - Implant Uncovering Bur - Small |