PMMA CAD/CAM Disc - Dental crown/bridge, temporary - POLIDENT d.o.o.

Duns Number:644778409

Device Description: Dental crown/bridge, temporary

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More Product Details

Catalog Number

PMMAML.599

Brand Name

PMMA CAD/CAM Disc

Version/Model Number

PMMAML.599

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Device Record Status

Public Device Record Key

906e8883-851e-43b5-a376-106ab3698247

Public Version Date

June 23, 2021

Public Version Number

1

DI Record Publish Date

June 15, 2021

Additional Identifiers

Package DI Number

EPOLPMMAML59903

Quantity per Package

1

Contains DI Package

EPOLPMMAML599

Package Discontinue Date

June 15, 2021

Package Status

Not in Commercial Distribution

Package Type

plastic card

"POLIDENT D.O.O." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3891