AccessGUDID - DEVICE: Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material (D0026057101)

GUDID

Device Identifier (DI) Information

Brand Name: Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material
Version or Model: 605710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 605710
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026057101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Jeltrate® Chroma Dustless Color-Changing Alginate Impression Material, Fast Set Intro Kit Case

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:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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 10 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Weight: 454 Gram
Device Size Text, specify: Case of 9 Canisters Fast Set Intro Kit (454g each) contains: 1 Pouch Jeltrate® Chroma Material (454g), 1 Water Measure, 1 Powder Scoop

Device Record Status

Public Device Record Key: ff8d89d3-7e15-490c-8aac-4464bdda858f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016