ACE MIXING WELLS-WHITE-12 PKG

Basic Information

• Brand Name: ACE MIXING WELLS-WHITE-12 PKG
• Primary DI: D757X80498B1
• Version / Model: X-80498B
• Catalog Number: X-80498B
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-26
• Public Version: 3
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: d7053dd1-35ea-41d9-989a-d6fabfbebfca
• Distribution End Date: 2020-02-04

Device Description

ACE MIXING WELLS-WHITE-12 PKG

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXR	Applicator, Resin	Dental	872.3140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63877	Dental material mixing surface, chairside, reusable	A slab, tray, or well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D757X80498B1	HIBCC

Customer Contacts

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