NATURE-CRYL®

Basic Information

• Brand Name: NATURE-CRYL®
• Primary DI: 10386040007269
• Version / Model: 349667
• Catalog Number: 349667
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-11
• Public Version: 1
• Public Version Date: 2022-07-19
• Public Version Status: New
• Public Device Record Key: 307cc41c-cd0a-4c52-9a20-f64f80fe45f4

Device Description

NATURE-CRYL® MC CLEAR 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
63591	Dental acrylic resin	A non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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	10386040007269	GS1

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