ALPHA-DENT® One Step Primer - ALPHA-DENT® One Step Primer is part of the - DENTAL TECHNOLOGIES, INC.

Duns Number:148312838

Device Description: ALPHA-DENT® One Step Primer is part of the Paste-Primer system formulated to bond to metal ALPHA-DENT® One Step Primer is part of the Paste-Primer system formulated to bond to metal, ceramic and plastic brackets. Kit Contains: 1 x 12ml Primer

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More Product Details

Catalog Number

209.0101.001

Brand Name

ALPHA-DENT® One Step Primer

Version/Model Number

209.0101.001

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

-

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

K921044

Product Code Details

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Device Record Status

Public Device Record Key

b09d529c-5846-4f52-b6a4-734fe503396e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 183