AccessGUDID - DEVICE: Aquasil® Ultra Monophase Smart Wetting® Impression Material (D0026786821)

GUDID

Device Identifier (DI) Information

Brand Name: Aquasil® Ultra Monophase Smart Wetting® Impression Material
Version or Model: 678682
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 678682
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026786821
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Aquasil® Ultra+ Medium Regular Set DECA 5:1 (2-pack)

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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being 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
Total Volume: 380 Milliliter
Device Size Text, specify: 2 (380mL) DECA Cartridges, 20 mixing tips, 1 bayonet ring

Device Record Status

Public Device Record Key: 75a8c76a-bc8c-4494-a230-d229ee317089
Public Version Date: August 26, 2019
Public Version Number: 4
DI Record Publish Date: September 21, 2016