Duns Number:324914910
Device Description: Baltic Denture System BDLoad Tooth Shade Lm6 PLSEbil2DFl A2light
Catalog Number
1036386
Brand Name
Baltic Denture System BDLoad
Version/Model Number
Baltic Denture System BDLoad Tooth Shade Lm6 PLSEbil2DFl A2light
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKO
Product Code Name
Denture Preformed (Partially Prefabricated Denture)
Public Device Record Key
45e563e3-0b08-4f07-814d-d8f4616daa5d
Public Version Date
March 12, 2020
Public Version Number
1
DI Record Publish Date
March 04, 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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 12495 |
U | Unclassified | 15 |