AccessGUDID - DEVICE: Alpha-Dent® Alginate Flavorings (D73562031020010)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha-Dent® Alginate Flavorings
Version or Model: 620.3102.001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 620.3102.001
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73562031020010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: Alpha-Dent® Alginate Flavorings (Cookie Dough) 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).

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	Material, Impression

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K940120	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8760e95-6590-4dff-ae3b-84445e90305b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016