Catalog Number

H-812A2S

Brand Name

AELITE A.P.Body A2 Syr SMPL

Version/Model Number

H-812A2S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 24, 2019

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

K982729

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

cc1608a2-9566-493b-a4c2-dd644e86e057

Public Version Date

July 25, 2019

Public Version Number

4

DI Record Publish Date

June 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-