Purzir - Purzir Dental Zirconia Blank - Seattle Bioceramics, Inc.

Duns Number:118155468

Device Description: Purzir Dental Zirconia Blank

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More Product Details

Catalog Number

-

Brand Name

Purzir

Version/Model Number

MMT Plus A3 98-14

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K193055

Product Code Details

Product Code

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

456f5261-61a6-4746-bfca-66a79a822521

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEATTLE BIOCERAMICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1000