Catalog Number

SBE-100

Brand Name

DENTAL EQUIPMENTS

Version/Model Number

SMART BOX w/BLACK CAP 100 u.

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EGG

Product Code Name

Attachment, Precision, All

Public Device Record Key

7465bf19-cc25-4b03-a77d-7acac3f0afdf

Public Version Date

January 28, 2021

Public Version Number

2

DI Record Publish Date

January 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-