Primary Device ID | D101SGI1590 |
NIH Device Record Key | 75361f87-05c6-456c-b103-9298c395119f |
Commercial Distribution Discontinuation | 2999-01-01 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Stoneglass Industries |
Version Model Number | SGI159 |
Catalog Number | SGI159 |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D101SGI1590 [Primary] |
NSL | Dentures, Full |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-15 |
Device Publish Date | 2024-04-05 |
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 |