Duns Number:120580910
Device Description: NATURAL 1 POSTERIOR KIT CONTAINING COMP. BOND AND 48 CROWN SHELLS SIZES 2-31 SMALL, MEDIUM NATURAL 1 POSTERIOR KIT CONTAINING COMP. BOND AND 48 CROWN SHELLS SIZES 2-31 SMALL, MEDIUM & LARGE
Catalog Number
-
Brand Name
DIRECTCROWN
Version/Model Number
NAT1K
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
81438eae-0fc7-4435-9ccc-e715a11a7807
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
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. | 9 |