Catalog Number

-

Brand Name

DENTIN ONE PIECE IMPLANTS

Version/Model Number

DOP-1325

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120530,K120530

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

db3b0553-9774-461a-a3ef-d1a8d6e878c3

Public Version Date

October 11, 2018

Public Version Number

1

DI Record Publish Date

September 10, 2018

Package DI Number

07290113351806

Quantity per Package

10

Contains DI Package

07290113350809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-