N.A. - CONTEC lcr disposable tube / For CONTEC lcr - DENTAURUM GmbH & Co.KG

Duns Number:315427286

Device Description: CONTEC lcr disposable tube / For CONTEC lcr retainer adhesive (REF 163-131-00).

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More Product Details

Catalog Number

-

Brand Name

N.A.

Version/Model Number

163-120-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 22, 2022

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

K030644,K030644

Product Code Details

Product Code

DYH

Product Code Name

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Device Record Status

Public Device Record Key

f5ffce81-4529-4eeb-8271-c56e92a0c182

Public Version Date

January 24, 2022

Public Version Number

2

DI Record Publish Date

October 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAURUM GMBH & CO.KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2768
2 A medical device with a moderate to high risk that requires special controls. 1745