SciPharm Cure-On Touch Orthodontic Adhesive - Cure-On Touch is a direct bonding material and is - SCIENTIFIC PHARMACEUTICALS, INC.

Duns Number:096010525

Device Description: Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Acti Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.

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More Product Details

Catalog Number

65-126

Brand Name

SciPharm Cure-On Touch Orthodontic Adhesive

Version/Model Number

SP 65-126

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

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

K791132

Product Code Details

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Device Record Status

Public Device Record Key

021d4b23-8915-46a8-8f3d-8ac24d015936

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCIENTIFIC PHARMACEUTICALS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 476