| Primary Device ID | D101SGI190 |
| NIH Device Record Key | 73bce13c-79ee-4c78-a467-e5a02edf3fe2 |
| Commercial Distribution Discontinuation | 2999-01-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stoneglass Industries |
| Version Model Number | SGI19 |
| Catalog Number | SGI19 |
| Company DUNS | 751548632 |
| Company Name | STONEGLASS DENTAL LABORATORY PTY 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 | true |
| 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 |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au | |
| Phone | +61297641036 |
| pdc@stoneglass.com.au |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D101SGI190 [Primary] |
| NSN | Restoration, Resin, Crown And Bridge |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-06 |
| Device Publish Date | 2022-04-28 |
| D101SGI770 | Complete acrylic denture with polished and glazed gingival contouring |
| D101SGI750 | Complete acrylic denture with detailed gingival contour characterization |
| D101SGI50 | Complete Denture with Metal Reinforcement |
| D101SGI220 | ABC+DR Removable Prosthesis (Denture Teeth) |
| D101SGI200 | ABC+Z Prosthesis (Zirconia) |
| D101SGI190 | ABC+E Prosthesis (eMax) |
| D101SGI180 | ABC+D Prosthesis (Denture Teeth) |
| D101SGI160 | Fixed Prototype Prosthesis with Denture Teeth |
| D101SGI1080 | Replacement crown and repair for ABC+Z prosthesis |
| D101SGI1040 | Replacement crown and repair for ABC+E prosthesis |
| D101SGI870 | Temporary Prosthesis For Temporary Cylinder Support |
| D101SGI1050 | Temporary Prosthesis Assembled with Temporary Cylinders |
| D101SGI650 | Replacement Toothcard for ABC+D |
| D101SGI240 | Tooth Borne e.max Layered Crown |
| D101SGI170 | Fixed Prototype Prosthesis with PMMA Teeth |
| D101SGI1430 | Denture Obturator |
| D101SGI1250 | Dentabite Occlusal Splint |
| D101SGI1490 | Dentabite Occlusal Splint |
| D101SGI280 | Zirconia crown |
| D101SGI1590 | Dentabite Occlusal Splint |