Stick and Place - Stick and Place veneer placing instruments - RELIANCE ORTHODONTIC PRODUCTS INC

Duns Number:113170088

Device Description: Stick and Place veneer placing instruments

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More Product Details

Catalog Number

SNP16

Brand Name

Stick and Place

Version/Model Number

SNP16

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2016

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

KXR

Product Code Name

Applicator, Resin

Device Record Status

Public Device Record Key

bab2d72d-0325-4209-8886-44a0c15115b2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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