Catalog Number

8805101

Brand Name

Set PP

Version/Model Number

SET PP A1 SYR 2 PK

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

-

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

K073043,K073043

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

8a607c06-d749-497a-af7f-b3b8f07cc0bf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-