TEMREX BRASS "T" MATRIX BAND - A stainless steel band that is used to form a - TEMREX CORPORATION

Duns Number:012072823

Device Description: A stainless steel band that is used to form a mould around a tooth for the insertion of re A stainless steel band that is used to form a mould around a tooth for the insertion of restorative materials.

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More Product Details

Catalog Number

-

Brand Name

TEMREX BRASS "T" MATRIX BAND

Version/Model Number

91-96

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

DZN

Product Code Name

Instruments, Dental Hand

Device Record Status

Public Device Record Key

dfc175de-eb1d-43d4-8bcf-5b2d8d64e395

Public Version Date

March 17, 2022

Public Version Number

1

DI Record Publish Date

March 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEMREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 40