Essiz A+ - Essix A+ Plastic .120 x 125mm PETG Circle 25PK - RAINTREE ESSIX INC.

Duns Number:801157132

Device Description: Essix A+ Plastic .120 x 125mm PETG Circle 25PK

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More Product Details

Catalog Number

13125

Brand Name

Essiz A+

Version/Model Number

13125

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"

Yes

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

447ff05a-ca21-4547-a1aa-bcc61a81e987

Public Version Date

January 27, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RAINTREE ESSIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 103
U Unclassified 13