BIOCRYL XR 1# KIT

Basic Information

• Brand Name: BIOCRYL XR 1# KIT
• Primary DI: D7750480020
• Version / Model: 048-002
• Company Name: Great Lakes Dental Technologies, Ltd.
• Labeler DUNS: 041854332
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-11
• Public Version: 4
• Public Version Date: 2021-02-02
• Public Version Status: Update
• Public Device Record Key: c4514970-af9b-42a9-85b1-7a5fb57c0b91

Device Characteristics

• Single Use: Yes
• 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
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16727	Dental prosthesis restorative material, unfilled resin	A material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7750480020	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083479	000