JET SEAL LIQUID - SURFACE SEALANT FOR ACRYLIC RESIN - LANG DENTAL MANUFACTURING CO., INC.

Duns Number:005185798

Device Description: SURFACE SEALANT FOR ACRYLIC RESIN

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More Product Details

Catalog Number

4102C

Brand Name

JET SEAL LIQUID

Version/Model Number

30 ML

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

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

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

b5dc7cd7-e42a-4da8-b2dc-64669450569c

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

March 22, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LANG DENTAL MANUFACTURING CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 1018