Z-Prime Plus

Basic Information

• Brand Name: Z-Prime Plus
• Primary DI: D757B6003PS1
• Version / Model: B-6003PS
• Catalog Number: B-6003PS
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 7
• Public Version Date: 2022-10-11
• Public Version Status: Update
• Public Device Record Key: 67bcf647-803a-4b98-be05-36b2857450ee
• Distribution End Date: 2022-10-10

Device Description

Z-Prime Plus .5ml SMPL 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KLE	AGENT, TOOTH BONDING, RESIN	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62474	Dental prosthesis priming agent	A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D757B6003PS1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091705	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius