Assure Plus - Assure Plus resin is intended to increase - RELIANCE ORTHODONTIC PRODUCTS INC

Duns Number:113170088

Device Description: Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel

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More Product Details

Catalog Number

UAP50

Brand Name

Assure Plus

Version/Model Number

UAP50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 19, 2020

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

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

be5823f5-2762-45f7-9df6-3d2162523836

Public Version Date

May 20, 2020

Public Version Number

4

DI Record Publish Date

September 04, 2016

Additional Identifiers

Package DI Number

D798UAP502

Quantity per Package

100

Contains DI Package

D798UAP501

Package Discontinue Date

May 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Box

"RELIANCE ORTHODONTIC PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 73
2 A medical device with a moderate to high risk that requires special controls. 279