Denture, restoration - Modern Dental Laboratory (DG) Co., Ltd.

Duns Number:551746187

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More Product Details

Catalog Number

-

Brand Name

Denture, restoration

Version/Model Number

312

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)

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

NSJ

Product Code Name

Restoration, Noble Metal

Device Record Status

Public Device Record Key

2a9f011c-e995-458a-85d9-e715730e02b8

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

July 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MODERN DENTAL LABORATORY (DG) CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 24