Identity
- Trade Name
- Global Dental Science FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Denture Base Material FDA UDI
- Model / Reference
- PMMA Puck FDA UDI
- Description
- Denture Base Material FDA UDI
Identifiers
- Primary DI / UDI-DI
- D843GDS9825AVO0 FDA UDID843GDS9825OM30 FDA UDID843GDS9820B10 FDA UDI
- 510(k) Number
- K153590 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, thermoplastic
Global Dental Science by Global Dental Science — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153590 also covers:
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
- AvaDent — Global Dental Science
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Global Dental Science
Sources (3)
- FDA UDI dfc41f01-56d8-47e1-9c47-2c7a1186b6df 36 fields · synced Jun 8, 2026
- FDA UDI c52ea6a2-43be-44cd-9cc7-172e57f6647c 36 fields · synced May 26, 2026
- FDA UDI 88289eb6-decb-44da-8041-db4270063efb 36 fields · synced May 27, 2026