QUICK-DIE Refill Package

Basic Information

• Brand Name: QUICK-DIE Refill Package
• Primary DI: D757L11090P1
• Version / Model: L-11090P
• Catalog Number: L-11090P
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-06
• Public Version: 2
• Public Version Date: 2019-04-04
• Public Version Status: Update
• Public Device Record Key: 60e969a5-27ea-40bb-9a96-7dc21929afa7
• Distribution End Date: 2019-04-03

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: 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
34811	Polymer-based dental model material	A variety of dental materials dedicated for modelling and for use during production of dental restorations. It is based on various kinds of polymers. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D757L11090P1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K962680	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			sixe text

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius