Catalog Number

NA0811

Brand Name

Dental Porous Morsels 1.0g

Version/Model Number

NA0811

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

K112428

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

394c593f-68b3-49f8-90c0-9375c2d4055b

Public Version Date

April 14, 2021

Public Version Number

1

DI Record Publish Date

April 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-