Identity
- Trade Name
- Digital Denture FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin. FDA UDI
- Model / Reference
- 3014680794 FDA UDI
- Description
- Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810002220128 FDA UDI
- FDA Product Code
- PZY FDA UDIEBI FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3590 FDA UDI872.3760 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Digital Denture by Johns Dental Laboratory — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Johns Dental Laboratory
Sources (1)
- FDA UDI 85474cc0-dab8-40c9-b956-afa0ab10a234 34 fields · synced May 30, 2026