Aquasil Ultra Smart Wetting® Imp Material in digit® Targeted Delivery System

Basic Information

• Brand Name: Aquasil Ultra Smart Wetting® Imp Material in digit® Targeted Delivery System
• Primary DI: D0026782441
• Version / Model: 678244
• Catalog Number: 678244
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2022-10-03
• Public Version Status: Update
• Public Device Record Key: 5602a8b6-dad8-4ee1-b597-44b6156f3baa
• Distribution End Date: 2020-11-01

Device Description

Aquasil Ultra digit® LV Fast Set Smart Wetting® Impression Material, (Teal), with B4™ Optimizer in digit® Targeted Delivery System Cartridge Refill Package - Small Unit Doses

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELW	MATERIAL, IMPRESSION	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0026782441	HIBCC
Unit of Use	D0026782440	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			50 LV Fast Set Small Unit Doses, 50 Mixing Tips, 50 Intraoral Tips, 1 6mL Bottle B4™ Surface Optimizer, 50 Flocked Applicator Tips, 1 Dispensing Well

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight. Keep dry.