Hygenic

Basic Information

• Brand Name: Hygenic
• Primary DI: D661H015010
• Version / Model: H01501
• Company Name: COLTENE/WHALEDENT INC
• Labeler DUNS: 622185718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e32aeb52-37dd-41d0-8490-a1c2e0c6f4df

Device Description

Calcium Hydroxide Points #45-80

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
EJK	Liner, Cavity, Calcium Hydroxide	Dental	872.3250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16182	Dental cavity liner	A substance intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth from chemical irritation. The device is typically a thin layer of zinc oxide (ZnO) and eugenol (C10H12O2), or calcium hydroxide (Ca(OH)2). 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	D661H015010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973539	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 25 Degrees Celsius