Alpha-Dent® Alginate Flavorings - Alpha-Dent® Alginate Flavorings (Cinnamon) add a - DENTAL TECHNOLOGIES, INC.

Duns Number:148312838

Device Description: Alpha-Dent® Alginate Flavorings (Cinnamon) add a unique and pleasant flavor to each algina Alpha-Dent® Alginate Flavorings (Cinnamon) add a unique and pleasant flavor to each alginate mixture. The fun flavors provide patients with a wide choice, making impression taking experience more enjoyable. Simple to use, just add 5 to 7 drops for every scoop of powder. The bottle contains 2 fl. oz. (59.2ml).

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More Product Details

Catalog Number

620.0802.001

Brand Name

Alpha-Dent® Alginate Flavorings

Version/Model Number

620.0802.001

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

K940120

Product Code Details

Product Code

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

80527dfa-b4c6-4092-8b49-128b9febc8ab

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