Duns Number:657513573
Device Description: Abutment Ø5.5, 4.0 mm Abt. HThe Ti-one 101 Dental Implant System is a device made of pure Abutment Ø5.5, 4.0 mm Abt. HThe Ti-one 101 Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.
Catalog Number
-
Brand Name
Ti-one 101
Version/Model Number
HF01-713040
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110425
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
9e0ebb35-f93b-4a2f-82e9-203f9c129842
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 24, 2015
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. | 104 |