Sinfony™ - 3M™ ESPE™ Sinfony™ Deluxe Set, 69400 - 3M Deutschland GmbH

Duns Number:315731711

Device Description: 3M™ ESPE™ Sinfony™ Deluxe Set, 69400

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More Product Details

Catalog Number

69400

Brand Name

Sinfony™

Version/Model Number

69400

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

de484b9e-c282-4aec-a0f1-dfa877199627

Public Version Date

December 10, 2018

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M DEUTSCHLAND GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 232
2 A medical device with a moderate to high risk that requires special controls. 563
U Unclassified 3