AccessGUDID - DEVICE: Alpha-Dent® Alginate Impression Material (D73560405030010)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha-Dent® Alginate Impression Material
Version or Model: 604.0503.001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 604.0503.001
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73560405030010
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 Impression Material is available in a variety of flavors and set types. This heavy body material is designed to produce consistent impressions. Each can includes powder scoop and vial.

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 [?]
K790595	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
Storage Environment Temperature: between 22 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad738992-99ab-4e4e-bc01-a0420df5af86
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016