Catalog Number

P0-P64,5

Brand Name

Presthetic Accessories

Version/Model Number

P0-P64,5

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

317ede14-369f-4509-980c-15dbe6b0ac55

Public Version Date

January 16, 2020

Public Version Number

2

DI Record Publish Date

August 08, 2019

Package DI Number

17290111272308

Quantity per Package

10

Contains DI Package

07290111272301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

beg