AccessGUDID - DEVICE: Aquasil Ultra Smart Wetting® Imp Material with B4™ in digit® Targeted Del System (D0026782421)

GUDID

Device Identifier (DI) Information

Brand Name: Aquasil Ultra Smart Wetting® Imp Material with B4™ in digit® Targeted Del System
Version or Model: 678242
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 678242
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026782421
Issuing Agency: HIBCC
Commercial Distribution End Date: November 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Aquasil Ultra digit® XLV Regular Set (Orange) Smart Wetting® Impression Material in digit® Targeted Delivery System Cartridge Refill Package with B4™ Optimizer - Small Unit Doses

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:	Yes
Prescription Use (Rx):	No
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?
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
Special Storage Condition, Specify: Keep out of direct sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 50 XLV Regular Set Small Unit Doses, 50 Mixing Tips, 50 Intraoral Tips, 1 6mL Bottle B4 Surface Optimizer, 50 Flocked Applicator Tips, 1 Dispensing Well

Device Record Status

Public Device Record Key: a1f73f3e-1695-4933-997f-43c78b78389d
Public Version Date: October 03, 2022
Public Version Number: 3
DI Record Publish Date: September 21, 2016