SELECT TEMPORARY CEMENT TUBE PKG EUGENOL

Basic Information

• Brand Name: SELECT TEMPORARY CEMENT TUBE PKG EUGENOL
• Primary DI: D77819910630
• Version / Model: 199-1063
• Catalog Number: 199-1063
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 3
• Public Version Date: 2018-12-04
• Public Version Status: Update
• Public Device Record Key: 7e0fff70-17f7-40f5-b6c7-1d63aedc5779
• Distribution End Date: 2018-09-11

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: Yes
• 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
EMB	Zinc Oxide Eugenol	Dental	872.3275	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16710	Zinc phosphate dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid. It typically includes some additional fillers/components. 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	D77819910630	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 24 Degrees Celsius