Acid Etchant - ADHESIVE ACID ETCHANT LIQUID GREEN 37% 18g BOTTLE - AMERICAN ORTHODONTICS CORPORATION

Duns Number:044668515

Device Description: ADHESIVE ACID ETCHANT LIQUID GREEN 37% 18g BOTTLE

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More Product Details

Catalog Number

020-028536

Brand Name

Acid Etchant

Version/Model Number

020-028536

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

K872569

Product Code Details

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Device Record Status

Public Device Record Key

29c6d495-704d-437b-a825-1d5b4acf9d91

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

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