ZZ BASE ST-SA-WMSM-L15 4.6 (White Metal Scanmarker L15 with Screw) - Compatible with Straumann Screw-Retained Abutment - ZIRKONZAHN SRL

Duns Number:564251911

Device Description: Compatible with Straumann Screw-Retained Abutment White Metal Scanmarker consisting of: 1 Compatible with Straumann Screw-Retained Abutment White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw

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More Product Details

Catalog Number

-

Brand Name

ZZ BASE ST-SA-WMSM-L15 4.6 (White Metal Scanmarker L15 with Screw)

Version/Model Number

ZBED8032L15

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

NDP

Product Code Name

Accessories, implant, dental, endosseous

Device Record Status

Public Device Record Key

e9d2e3b6-2a00-4add-8bb3-43501d71dc87

Public Version Date

October 05, 2021

Public Version Number

1

DI Record Publish Date

September 27, 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