Identity
- Trade Name
- Stoneglass Industries FDA UDI
- Generic Name
- Preformed complete denture FDA UDI
- Device Name
- ABC+DR Removable Prosthesis (Denture Teeth) FDA UDI
- Model / Reference
- SGI22 FDA UDI
- Description
- ABC+DR Removable Prosthesis (Denture Teeth) FDA UDI
Identifiers
- Catalog Number
- SGI22 FDA UDI
- Primary DI / UDI-DI
- D101SGI220 FDA UDI
- FDA Product Code
- NSL FDA UDI
- GMDN Term
- Preformed complete denture FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Preformed complete denture
Stoneglass Industries by Stoneglass Dental Laboratory Pty Ltd — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Preformed complete denture.
- Baltic Denture System BD Load — Merz Dental GmbH · Class II
- Baltic Denture System BD Load — Merz Dental GmbH · Class II
- Baltic Denture System BDLoad — Merz Dental GmbH · Class II
- Baltic Denture System BD Load — Merz Dental GmbH · Class II
- Baltic Denture System BDLoad — Merz Dental GmbH · Class II
- Baltic Denture System BDLoad — Merz Dental GmbH · Class II
- Baltic Denture System BD Load — Merz Dental GmbH · Class II
- Baltic Denture System BDLoad — Merz Dental GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stoneglass Dental Laboratory Pty Ltd
Sources (1)
- FDA UDI d3c13898-39ec-49f8-aac5-8b99533356a1 36 fields · synced Jun 8, 2026