Duns Number:080134511
Device Description: Anatotemp Anatomic Dental Implant Healing Abutment 3.5mmD Platform Internal Tri-Lobe Conne Anatotemp Anatomic Dental Implant Healing Abutment 3.5mmD Platform Internal Tri-Lobe Connection Maxillary Lateral/Mandibular Incisor
Catalog Number
-
Brand Name
Anatotemp
Version/Model Number
2035-02
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171922
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
97b62cbc-debb-4af9-b8b6-cd78a0d2254f
Public Version Date
December 07, 2018
Public Version Number
4
DI Record Publish Date
December 07, 2017
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. | 46 |