FDA UDI
In Commercial Distribution
🇺🇸 United States
Stoneglass Industries
DI: D101SGI1460
·
Model: SGI146
·
STONEGLASS DENTAL LABORATORY PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Stoneglass Industries
- Primary DI
- D101SGI1460
- Version / Model
- SGI146
- Catalog Number
- SGI146
- Company Name
- STONEGLASS DENTAL LABORATORY PTY LTD
- Labeler DUNS
- 751548632
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-12
- Public Version
- 1
- Public Version Date
- 2023-09-20
- Public Version Status
- New
- Public Device Record Key
- 65967ecb-be02-4841-b03f-8871c43b5b5b
- Distribution End Date
- 2999-01-01
Device Description
Temporary Tooth Borne Shell Bridge
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NSL | Dentures, Full | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11172 | Preformed complete denture | A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D101SGI1460 | HIBCC |
Customer Contacts
- Phone
- +61297641036
- [email protected]