Identity
- Trade Name
- Curve Image™ FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- Curve Image™ is a cloud-based dental image acquisition and management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer. FDA UDI
- Model / Reference
- CURVE-IMAGE-I FDA UDI
- Description
- Curve Image™ is a cloud-based dental image acquisition and management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D848CURVEIMAGE0 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology picture archiving and communication system workstation
Curve Image™ by Curve Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Curve Dental, Inc.
Sources (1)
- FDA UDI 9d08583e-ecc4-41f8-98a3-89f687960e6b 33 fields · synced Jun 1, 2026