Duns Number:487103033
Device Description: SDS1.2 healing cap-disc 9x12
Catalog Number
-
Brand Name
SDS1.2
Version/Model Number
SDS1.2_HC-disc-9x12
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181953
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
51793562-1fa6-47b1-8f6c-e68081d66bd0
Public Version Date
August 13, 2020
Public Version Number
1
DI Record Publish Date
August 05, 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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |