Ti-one 101 - Dental Implant Ø4.0, 11 mm LengthThe Ti-one 101 - HUNG CHUN BIO-S CO., LTD.

Duns Number:657513573

Device Description: Dental Implant Ø4.0, 11 mm LengthThe Ti-one 101 Dental Implant System is a device made of

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More Product Details

Catalog Number

-

Brand Name

Ti-one 101

Version/Model Number

HF01-104011

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

117e71fb-bdb1-4feb-8ca9-86be1bdd65aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HUNG CHUN BIO-S CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 104