UNIMETRIC 1 MM Special Penetration Drill - Endodontic Posts Drills - MAILLEFER INSTRUMENTS HOLDING Sàrl

Duns Number:480538495

Device Description: Endodontic Posts Drills

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More Product Details

Catalog Number

C021220021000

Brand Name

UNIMETRIC 1 MM Special Penetration Drill

Version/Model Number

C021220021000

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)

-

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

4daa7cff-99e1-4af5-8497-94e3ef984468

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAILLEFER INSTRUMENTS HOLDING SÀRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 832