Duns Number:202952487
Device Description: Curve Dental® develops and markets a cloud-based dental practice management system titled Curve Dental® develops and markets a cloud-based dental practice management system titled Curve Hero™. Using a Mac or PC platform, a dental practice can use Curve Hero™ to manage all aspects of their practice, from scheduling to charting to billing, or from front desk to operatory. The application provides for secure and redundant management of all patient records and patient communications. Additionally, when utilizing Curve Dental’s® Curve Image™, the practice can also capture digital images directly to the cloud.
Catalog Number
-
Brand Name
Curve Hero™
Version/Model Number
CURVE-HERO-I
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
4f098fce-dfd1-4d1a-bc75-fcfce9ba332c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 10, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |