Catalog Number

VPSAD301

Brand Name

Alpine Dental

Version/Model Number

AD301

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

7e38be55-38d1-4fa8-bd84-7f7748b0f36c

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2019

Package DI Number

D922VPSAD3001

Quantity per Package

100

Contains DI Package

D922VPSAD3010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box