Catalog Number

NA0611

Brand Name

Dental Putty 1.0cc

Version/Model Number

NA0611

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

K100671

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

b88a2ce0-eb60-4a74-a74f-adbce59c3a42

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-