Grandio blocs - 5x Gr. 14L A1 HT (HighTranslucent) - VOCO GmbH

Duns Number:316699578

Device Description: 5x Gr. 14L A1 HT (HighTranslucent)

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More Product Details

Catalog Number

6177

Brand Name

Grandio blocs

Version/Model Number

6177

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

K171200,K171200

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

b36ce2c5-e54b-43ae-ab5d-61309526e704

Public Version Date

January 27, 2022

Public Version Number

1

DI Record Publish Date

January 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VOCO GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 396
U Unclassified 5