NATURE-CRYL®

Basic Information

• Brand Name: NATURE-CRYL®
• Primary DI: D6583496621
• Version / Model: 349662
• Catalog Number: 349662
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6ea05f36-b745-4537-ab5f-d99b420ae54c

Device Description

NATURE-CRYL® MC COE-LOR MODERATE 1:1 PKG (1Ib powder, 8oz liquid)

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
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16729	Denture base resin, heat-cured	A resin that requires heat for polymerization intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually consists of an acrylic monomer of methyl methacrylate (typically supplied as a powder) that becomes a polymer (polymethylmethacrylate or PMMA) when mixed with a catalyst such as benzoylperoxide (typically supplied as a liquid). Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6583496621	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K991774	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 27 Degrees Celsius