PRETTAU 3 Dispersive A2 1 - Content: 1 piece Height: 16 mm - ZIRKONZAHN SRL

Duns Number:564251911

Device Description: Content: 1 piece Height: 16 mm

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More Product Details

Catalog Number

-

Brand Name

PRETTAU 3 Dispersive A2 1

Version/Model Number

ZROC0101A02

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

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

4d53c4ff-23b3-4fab-981c-136617254c3f

Public Version Date

April 07, 2021

Public Version Number

1

DI Record Publish Date

March 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIRKONZAHN SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1369
2 A medical device with a moderate to high risk that requires special controls. 4845
U Unclassified 3