BracePaste - ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 2/PK

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More Product Details

Catalog Number

020-033120

Brand Name

BracePaste

Version/Model Number

020-033120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K160782

Product Code Details

Product Code

DYH

Product Code Name

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Device Record Status

Public Device Record Key

1cecba9f-8b58-42a4-8883-dd6359a83f50

Public Version Date

October 14, 2020

Public Version Number

1

DI Record Publish Date

October 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN ORTHODONTICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16634
2 A medical device with a moderate to high risk that requires special controls. 982