Identity
- Trade Name
- AvaDent FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- PMMA Puck, CAD-CAM denture base material FDA UDI
- Model / Reference
- PCK6500 FDA UDI
- Description
- PMMA Puck, CAD-CAM denture base material FDA UDI
Identifiers
- Primary DI / UDI-DI
- D843GDS9822AVCL0 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, thermoplastic
AvaDent by Global Dental Science — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, thermoplastic.
- Proform — Keystone Industries · U
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Vertex-Dental BV — Vertex-Dental B.V. · Class II
- FlexiNylon cartridges Natural — Perflex · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- G-CAM — GRAPHENANO DENTAL SL. · Class II
- Clear Advantage — ORTHO TECHNOLOGY, INC. · Class I
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 (1)
- FDA UDI 9b540b86-93e3-475e-b8ad-0400725d04ac 36 fields · synced May 30, 2026