SUPER LUX A1-D4 X8 UPPER A2-1/74 - SUPER LUX A1-D4 , EIGHT ARTIFICIAL TEETH, UPPER, - MAJOR PRODOTTI DENTARI SPA

Duns Number:459034567

Device Description: SUPER LUX A1-D4 , EIGHT ARTIFICIAL TEETH, UPPER, SHADE A2, MOULD 1/74

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More Product Details

Catalog Number

T3012

Brand Name

SUPER LUX A1-D4 X8 UPPER A2-1/74

Version/Model Number

Shade A2, Mould 1/74

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

Yes

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

ELM

Product Code Name

Denture, Plastic, Teeth

Device Record Status

Public Device Record Key

516b9a44-14b9-41f4-be0b-a517ecb78403

Public Version Date

October 16, 2019

Public Version Number

1

DI Record Publish Date

October 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAJOR PRODOTTI DENTARI SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2205