AccessGUDID - DEVICE: Jeltrate® Dustless Alginate Impression Material (D0026052001)

GUDID

Device Identifier (DI) Information

Brand Name: Jeltrate® Dustless Alginate Impression Material
Version or Model: 605200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 605200
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026052001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Jeltrate® Dustless Alginate Impression Material, Fast Set, Case of 8 pouches

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 [?]
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
Special Storage Condition, Specify: Protect from humidity and excessive heat.
Storage Environment Temperature: between 18 and 29 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 454 Gram
Device Size Text, specify: Case of 8 Pouches, each with 1 Accessory Pack and 1 Empty Canister, Fast Set (454g each)

Device Record Status

Public Device Record Key: c8b3393d-f37b-49fe-bd35-954c9f7fa8ff
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016