Duns Number:006385173
Device Description: A dental articulator is a device designed to simulate all or part of the mandibular moveme A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.
Catalog Number
20011382
Brand Name
Denar Mark 310 Articulator
Version/Model Number
20011382
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJP
Product Code Name
Articulators
Public Device Record Key
d5eabb68-e70b-41fe-975e-75b519bf586d
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 293 |
| U | Unclassified | 1 |