Duns Number:078352849
Device Description: Integrity Implant Abutment 3.7 - 4.5mm x 0° (Straight) -7mm Height. To fit Integrity Impla Integrity Implant Abutment 3.7 - 4.5mm x 0° (Straight) -7mm Height. To fit Integrity Implants diameter sizes 3.7 to 4.5 mm.
Catalog Number
PITI-3.7 - 4.5 (0°)
Brand Name
Tatum Surgical Integrity Abutment
Version/Model Number
Abutment3.7 - 4.5mm x 0° (Straight) Integrity Post
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K811923
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
28bbe28d-aebf-4a26-829a-a4466bbf4ade
Public Version Date
June 21, 2021
Public Version Number
2
DI Record Publish Date
November 17, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |