Absolute Dentin™ - Absolute Dentin™ 50ml - Blue for Korea - PARKELL, INC.

Duns Number:009900424

Device Description: Absolute Dentin™ 50ml - Blue for Korea

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More Product Details

Catalog Number

S307-K

Brand Name

Absolute Dentin™

Version/Model Number

S307-K

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)

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

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

8bee28ed-5f5f-4c03-b528-f337a17359cf

Public Version Date

October 11, 2021

Public Version Number

1

DI Record Publish Date

October 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKELL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 476
U Unclassified 19