Ceramill TEMP - Ceramill TEMP middle 71 L20mm US - Merz Dental GmbH

Duns Number:324914910

Device Description: Ceramill TEMP middle 71 L20mm US

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More Product Details

Catalog Number

760330

Brand Name

Ceramill TEMP

Version/Model Number

Ceramill TEMP middle 71 L20mm US

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071548

Product Code Details

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

80e0f52d-5492-4d3e-a5cb-5be758d06228

Public Version Date

December 13, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERZ DENTAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 12495
U Unclassified 15