Matrix Strip - Dead soft matrix strip, (001”/.025 mm) 20’ roll - PULPDENT CORPORATION

Duns Number:001006089

Device Description: Dead soft matrix strip, (001”/.025 mm) 20’ roll

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More Product Details

Catalog Number

-

Brand Name

Matrix Strip

Version/Model Number

M-DS

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

-

Product Code Details

Product Code

JEP

Product Code Name

Retainer, Matrix

Device Record Status

Public Device Record Key

50be019e-939d-4fa9-a6e1-0d9db52bb9ec

Public Version Date

September 30, 2021

Public Version Number

1

DI Record Publish Date

September 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PULPDENT CORPORATION" 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. 177