DT LIGHT POST System Kit - BISCO INC.

Duns Number:053529939

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More Product Details

Catalog Number

G-91320K

Brand Name

DT LIGHT POST System Kit

Version/Model Number

G-91320K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 10, 2020

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

DZA

Product Code Name

DRILL, DENTAL, INTRAORAL

Device Record Status

Public Device Record Key

465bbce1-ef22-4792-a629-7d6b126e9ee3

Public Version Date

September 25, 2020

Public Version Number

3

DI Record Publish Date

June 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BISCO INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 335
2 A medical device with a moderate to high risk that requires special controls. 675