ALPHA-DENT® Self Cure Bracket Bonding Resin - ALPHA-DENT® Self Cure Bracket Bonding Resin is a - DENTAL TECHNOLOGIES, INC.

Duns Number:148312838

Device Description: ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimized bond failures. Kit Contains: 1 x 7ml Bracket Bonding Base

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More Product Details

Catalog Number

210.0101.001

Brand Name

ALPHA-DENT® Self Cure Bracket Bonding Resin

Version/Model Number

210.0101.001

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

K930614

Product Code Details

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Device Record Status

Public Device Record Key

63ee69cd-f3d8-4853-b75c-58143df6d7f0

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