StarDental Instrument Solutions - INSTR MG DE EXPL 16-17 - DENTALEZ, INC.

Duns Number:059010363

Device Description: INSTR MG DE EXPL 16-17

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More Product Details

Catalog Number

-

Brand Name

StarDental Instrument Solutions

Version/Model Number

202171

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

EKB

Product Code Name

Explorer, Operative

Device Record Status

Public Device Record Key

1dfe249a-9f60-4a7c-bb78-b9af669022d4

Public Version Date

December 06, 2018

Public Version Number

1

DI Record Publish Date

November 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTALEZ, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 160
2 A medical device with a moderate to high risk that requires special controls. 22