FuturaSelf Pink veined - Cold-curing repair resin for additions, replacing - Schütz Dental GmbH

Duns Number:315830349

Device Description: Cold-curing repair resin for additions, replacing teeth and other repairs

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More Product Details

Catalog Number

-

Brand Name

FuturaSelf Pink veined

Version/Model Number

650624

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

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

faa6d6ec-6282-49bd-9e0a-96f62e992d55

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHÜTZ DENTAL GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 390