Aquasil® Ultra Smart Wedding Impression Material

Basic Information

• Brand Name: Aquasil® Ultra Smart Wedding Impression Material
• Primary DI: D002678769KR1
• Version / Model: 678769KR
• Catalog Number: 678769KR
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2022-05-12
• Public Version: 1
• Public Version Date: 2022-05-20
• Public Version Status: New
• Public Device Record Key: 36ab47c0-068d-45cf-b1dd-3940c9b51a85

Device Description

Aquasil® Ultra XLV Regular Set Cartridge Refill (Asia Only)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
Unit of Use	D002678769KR0	HIBCC
Primary	D002678769KR1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4 Cartridges (50mL each)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use after expiration date.
• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Use the product at room temperature.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not store used cartridges with new (unused) mixing tips attached.
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from moisture.